Overall responsibility for all activities within the QC Laboratory, including Compliance, Stability Program, Raw material testing and finished product testing and release. Ensuring compliance with Regulatory, GMP, Health and Safety, Company Procedures and specifications and environmental while ensuring customer requirements and needs are met.5 days onsite in our QC LaboratoryAs our QC Lab Manager your key responsibilities will be as follows:Compliance:<ul><li>Ensuring that QC Compliance activities are performed as per the scheduled action plans, to ensure that the QC department has up to date documentation to complete processes and testing including, SOP, COI, ECP and other documentation.</li><li>Ensures that the necessary action is taken as per the procedural requirements when Deviations occur and that CAPA are completed and closed as required.</li><li>Actively participating in internal and external audits.</li><li>Evaluate and take action on trends within the QC laboratory.</li></ul>Laboratory:<ul><li>Ensure planning and completion of testing to allow for timely release of raw materials, in process samples, finished products, pilot batches and validation related samples.</li><li>Ensuring that all data verification is performed in accordance with requirements for data integrity and accuracy.</li><li>Oversight over the QC stability program, ensuring that the program is managed as per site and customer requirements, that out of specification results are investigated and that the necessary action is taken when required i.e. notification to authorities and customers.</li><li>Support the new product introduction process by ensuring new materials and products are tested as required by the relevant project plans and protocols.</li><li>Collaborate with Production, Planning and shipping to determine priorities for release.</li><li>Lead and motivate the analysts to achieve weekly / monthly targets and shipping dates.</li><li>Ensure that all testing is conducted in accordance with current EU and US regulatory requirements. Data integrity is of paramount importance and must comply with current guidelines. Ensure timely review and approval of laboratory results, protocols and reports.</li><li>Provide technical guidance in the event of any testing issue experienced including equipment failure, calibration failure, out of specification results, method issues or any other issues as appropriate.</li><li>Ensure all laboratory equipment is maintained and calibrated.</li><li>Ensure that standards, controlled substances are maintained, replenished and discarded as per the company procedures.</li><li>Assist in performing detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory.</li><li>Ensure the laboratory operates within the requirements of the Annual budget on a monthly basis. Safety:</li></ul><ul><li>Overall responsible to ensure that the QC laboratory is maintained in a safe and compliant way to ensure that personnel are performing their duties in a safe manner.</li><li>Coordinate safety related activities e.g. risk assessments, safety training etc with the EHS department. Training:</li><li>Ensure that all staff in the QC department are trained and competent to perform their duties.</li><li>Coordinate with internal and external parties to arrange suitable training with the ultimate goal of developing staff within the QC department.</li></ul>Skills &amp; Competencies:<ul><li>Strong Leadership and People Management skills essential with demonstrated ability to lead and motivate a team.</li><li>Strong Organisational and time management skills and the ability to prioritise competing demands.</li><li>Strong IT and technical skills and working knowledge of the most common analytical techniques &amp; relevant software.</li><li>String attitude to the ALCOA+ requirements.</li><li>Ability to build relationships and collaborate with others.</li><li>Excellent communication skills, both verbal &amp; written.</li><li>Strong analytical ability and associated problem solving.</li><li>Takes a methodical, systematic and structured approach to organising work.</li><li>Positive and proactive person who is energised by having great responsibility.</li><li>Practical, action-orientated approach to managing priorities and teams. The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required and may be subject to change.</li></ul>Qualifications &amp; Experience:<ul><li>3rd level qualification &ndash; bachelor&rsquo;s degree in a science-based discipline.</li><li>10-15 years in a pharmaceutical&rsquo;s environment of which at least 5 in senior or people management position.</li><li>Experience working within a QC lab within a pharmaceutical cGMP Environment; with knowledge of EU GMP essential.</li></ul>

QC Lab Manager

Quality Engineer - Shannon&nbsp; Our client is seeking an experienced Quality Engineer to join a growing team in Shannon, Co. Clare. This organisation has worldwide expertise but also a local presence within a specialized field in a fast-paced multi-national company background. Responsibilities:<ul><li>Maintaining and updating the QMS documentation/records/systems</li><li>Driving process efficiency, resolving/providing feedback on issues</li><li>Conducting and reporting on internal audits as per annual schedule and closing-out of any non-conformances that arise</li><li>Analysing, identify and implement manufacturing and/or business process improvements which will improve capability performance</li><li>Assisting engineering teams on product/process verification for new and existing products.</li><li>Running CAPA systems and all related tasks. Lead quality problem investigations using proven quality tools.</li><li>Assist with operating and maintaining calibration systems.</li><li>Managing and co-ordination of various quality related projects and quality aspects of production programs</li></ul>Requirements and Skills: <ul><li>Ideally you will have 2-3 years experience in a similar role or environment and have a good working knowledge of ISO9001 and/or AS9100 Quality Management Systems.</li><li>Experience of NPI activity is desirable</li><li>Proven to be self-directed, self-motivated and able to prioritize and resolve competing&nbsp; priorities.</li><li>Auditing experience in a manufacturing environment</li></ul>For further information on this role in please contact on Regina Carroll&nbsp; on 086 0100 903 or jobs@hero.ie Check out all our open jobs on our HERO Recruitment website &ndash; <a href="https://www.hero.ie/">https://www.hero.ie/</a> Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review

Quality Engineer 

Quality Associate Specialist The Quality Associate Specialist ensures adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures. The Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements. Role Functions <ul><li>Provide direct Quality support to production and support areas.</li><li>Provides presence on the shop floor to support compliance and data integrity.</li><li>Review and approve GMP documentation/data for accuracy and completeness.</li><li>Review and approve executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.</li><li>QA support, review and approval of C&amp;Q, Performance qualification (PQ) &amp; Process Validation documents.</li><li>Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance &amp; Calibration Programs.</li><li>Provides support to internal audits and regulatory inspections.</li><li>Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.</li></ul> Experience, Knowledge &amp; Skills General competencies:<ul><li>Motivation to be an inspiring member of a high performing team.</li><li>Desire to continuously learn, improve and develop.</li><li>Leadership skills coupled with good oral and written communication skills.</li><li>Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.</li></ul>&nbsp;Technical competencies:<ul><li>Knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field.</li><li>Technical writing skills.</li><li>Lean Six-sigma and problem solving tools.</li></ul> Education/Experience:<ul><li>Bachelor degree, in a scientific or engineering field.</li><li>3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function.</li></ul> Our Vision: To be recognised as the best STEM Contracting &amp; Permanent Recruitment company and the Employer of Choice for top performing Recruiters.For further information on this role please contact Geraldine Gormally on 0861071395&nbsp;&nbsp;<a href="mailto:/%C2%A0recruit@hero.ie">/&nbsp;recruit@hero.ie</a>Check out all our open jobs on our HERO Recruitment website &ndash;&nbsp;<a href="https://www.hero.ie/">https://www.hero.ie/</a>&nbsp;&nbsp;Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Quality Associate Specialist 

Senior Quality Assurance EngineerRole &amp; Responsibilities<ul><li>Support sustaining commercial projects from a Design Assurance perspective. You will be directly involved in making sure our products are maintained through the full product lifecycle and that these products comply with global standards.</li><li>Support the introduction/implementation of product/process/materials changes to the manufacturing operation. You will assess the patient risk appropriately for these design changes. You will provide QA technical direction/input to qualification and validation activities in conjunction with R&amp;D and Mfg. Engineering.</li><li>Responsible for generation of Design Verification protocols &amp; will participate in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.</li><li>Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.</li><li>Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment.</li><li>As part of ongoing professional development, you will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialization activities. You will generate and approve change requests. Lead investigation analysis and timely completion of same.</li><li>Collaborates with engineering and manufacturing functions to ensure quality standards are in place.</li><li>Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications</li><li>Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.</li><li>May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.</li><li>Collaborate with complaints team for complex investigations.</li><li>Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.</li></ul> Requirements<ul><li>Requires a Bachelor&rsquo;s degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.</li><li>Strong problem solving and analytical skills &nbsp;</li><li>Strong problem-solving skills with the ability to identify root causes and implement corrective actions.&nbsp;</li><li>Strong technical writing ability.</li><li>Applying Statistical Analysis &nbsp;</li><li>Design Verification &nbsp;</li><li>Dynamic team player who can work effectively and proactively on cross-functional teams &nbsp;</li><li>Good communicator and fluent in English, both in writing and speaking. &nbsp;</li><li>Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions. &nbsp;</li><li>Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures &nbsp;</li></ul> Our Vision: To be recognised as the best STEM Contracting &amp; Permanent Recruitment company and the Employer of Choice for top performing Recruiters.For further information on this role please contact Geraldine Gormally on 0861071395&nbsp;&nbsp;<a href="mailto:/%C2%A0recruit@hero.ie">/&nbsp;recruit@hero.ie</a>Check out all our open jobs on our HERO Recruitment website &ndash;&nbsp;<a href="https://www.hero.ie/">https://www.hero.ie/</a>&nbsp;&nbsp;Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Senior Quality Assurance Engineer 

Quality Engineer&nbsp;To ensure that products and manufacturing processes comply with all relevant quality, regulatory, and industry standards. This role will support and enhance the Quality Management System (QMS), ensuring adherence to regulations such as FDA, ISO, and other applicable standards. The Quality Engineer will collaborate with cross-functional teams to identify and resolve quality issues, conduct audits, and lead corrective and preventive actions (CAPAs).Key Responsibilities<ul><li>Maintain the Quality Management System (QMS) to ensure compliance with ISO 13485 and other relevant standards, continuously improving QMS documentation and processes.</li><li>Conduct product and process audits to ensure adherence to quality standards, regulatory requirements, and internal procedures, identifying areas for improvement.</li><li>Identify and resolve quality issues, collaborating with production, engineering, and other teams to implement corrective and preventive actions (CAPAs) to improve process efficiency.</li><li>Review and approve documentation such as device history records (DHRs), validation protocols, and change control records, ensuring accuracy and regulatory compliance.</li><li>Lead investigations for non-conformances, performing root cause analysis and implementing corrective actions to drive continuous improvement.</li><li>Conduct risk assessments for new and existing products, supporting risk management strategies in accordance with applicable standards.</li><li>Participate in supplier quality management, ensuring suppliers meet quality standards and conducting audits as needed.</li><li>Provide training and support to production, engineering, and other teams on quality standards, regulatory requirements, and best practices.</li><li>Monitor and report on key quality metrics, updating management on quality performance and areas for improvement.</li><li>Support product development projects, ensuring quality considerations are integrated throughout the product lifecycle.</li><li>Assist in preparation for regulatory inspections and audits, ensuring the company is always prepared for compliance evaluations.</li></ul>Education and Experience:<ul><li>Bachelor's degree in Engineering, Quality Management, or a related field.</li><li>3+ years of experience in a Quality Engineer role within a regulated industry (e.g., medical devices, pharmaceuticals, aerospace).</li><li>Experience working with Quality Management Systems (QMS) and standards such as ISO 13485 and FDA regulations.</li><li>Strong understanding of quality control principles, statistical analysis, and root cause analysis techniques.</li><li>Experience in conducting internal and supplier audits.</li><li>Ability to lead and implement corrective and preventive actions (CAPAs).</li><li>Knowledge of risk management principles and methodologies.</li><li>Excellent documentation and communication skills.</li><li>Ability to work effectively in a cross-functional team environment.</li></ul>For more on this contact Johanne at 086 4403725 or choices@hero.ieCheck out all our open jobs on our HERO Recruitment website &ndash; <a href="https://www.hero.ie/">https://www.hero.ie/</a>&nbsp;Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval&nbsp;Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. &nbsp;You have supplied us with your personal data in the process of applying for a position. &nbsp;Our client company may have personnel outside of the EEA who will review you data. &nbsp;We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Quality Engineer

I specialise in talent acquisition for diverse industries across Ireland. With a robust experience spanning over three decades, HERO Recruitment has earned a stellar reputation for our unwavering passion and commitment to excellence.
Our client portfolio is broad, covering sectors such as medical devices, pharmaceuticals, manufacturing, IT, and more. Armed with extensive connections, I can confidently locate the perfect match for you.
However, let's shift the focus to you &ndash; your dreams and goals are my driving force. Beyond being a recruiter, I am your dedicated partner, ready to guide you through every step of your journey. Together, we will navigate through various opportunities and transform your career aspirations into reality.
Join the HERO Recruitment family today, and let's co-create a success story that is uniquely yours. Together, we will make a substantial impact in the industry. Are you ready? Let's make it happen.

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