QUALITY ENGINEER (DAYS)

Job Summary:

• To ensure that products manufactured at the site complies with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements.
• To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved. Ensure that all actions comply with current good manufacturing practice.

 

Key Responsibilities:

 

• Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.
• Audit the quality system with other personnel where required.
• Assist in the investigation and coordination of customer complaints and assess the need for implementation of effective corrective or preventive actions.
• Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.
• Measure performance of the Quality System and provide metrics, for inclusion in the management review, monthly reports etc.
• Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
• Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
• Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance.
• Ensure implementation and compliance with relevant Regulator requirements.
• Assist in the performance of validation activities at the site.
• Ensure Quality System documentation is thorough, complete, and compliant.
• Ensure compliance with training requirements is maintained.
• Review lot records, ensuring documentation is compliant with requirements and completing lot release for shipment.
• Inspect incoming products and manage the supplier Quality relationship.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
• Complete in-process and final release product testing per the relevant approved specifications and procedures.
• Where required. Review batch records, ensuring documentation is compliant with requirements.
• Complete disposition decision for the batch.
• Participate in Risk Management activities as required.

 

Essential Requirements

 

• Degree in an Engineering, Science, Quality or other discipline

 

Desired Requirements

 

• A Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.

 

Experience Required

Technical/Business Knowledge

 

• 2 years plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.
• Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is desirable.
• Experience in an injection moulding or tooling environment is desirable.

 

Cognitive Skills

 

• The position requires a high level of attention to detail and mental concentration, to ensure total compliance with operating procedures and Regulations at all times.
• The position requires proven problem-solving skills, and the ability to adapt to new processes on a regular basis.
• The position requires proven technical skills, to ensure the person can cope with the technical demands of the position at all times.
• The position requires total commitment to quality and safety at all times.
• The position requires the ability to continuously improve the Quality System and methods of work.

 

Ownership/Accountability

 

• Has a personal responsibility to commit to the AbbVie Vision, to engage and align with the AbbVie Strategic Imperatives, and to consistently execute in accordance with the AbbVie Operational Pillars and AbbVie Ways of Work.
• This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies.
• Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
• The position has a high level of autonomy, and individuals are expected to work on their own initiative.
• Demonstrates an ethos of Right First Time at all times.
• Adheres to and follows all procedures, policies and guidelines ensuring compliance with cGMP and ISO/FDA regulations and company policies, procedures and guidelines.
• Shows a high level of tenacity to ensure closure of issues.

 

Influence/Leadership

 

• May be required to support Cross functional teams and cost improvement projects.
• Complies with cGMP at all times.
• Considerable and continual care and attention to detail is needed to detect and avoid errors.
• Continual attention needed to ensure plant reaches its Quality objectives.
• Leads by example through compliant behaviour / actions.

 

Decision Making/Impact

 

• Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment.
• Expected to handle all day-to-day training, learning & development queries, if major problem can refer to Quality Manager.
• Responsible for the presentation of technical data to stakeholders to ensure prompt decisions on training/learning and development related issues.

 

Supervision Received

 

• The incumbent has set targets and goals to achieve which are reviewed on a weekly/monthly basis.
• The incumbent receives only general instructions from management personnel as to manner to which duties should be performed.
• The incumbent is charged with responsibility for ensuring product compliance to specification and Quality System compliance.

 

Supervision Provided

 

• No direct reports. EHS Requirements
• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
• Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
• Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
• Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
• Attend all required EHS training and medical surveillance programs.
• Wear PPE as required.