Quality Engineer II
In this role, you will be responsible for ensuring that all materials, processes, and products meet the highest quality standards and comply with regulatory requirements. You will collaborate closely with cross-functional teams in engineering, manufacturing, and quality to implement effective inspection, testing, and control systems throughout the product lifecycle. This position offers the opportunity to apply your technical expertise in design control, quality engineering principles, and problem-solving to drive continuous improvement and ensure the delivery of safe, reliable, and compliant products.
Responsibilities may include the following and other duties may be assigned:
- Applies and maintains quality standards and protocols for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Apply knowledge of design control principles and quality engineering
- techniques throughout the product development process and the product
- Applies and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of raw materials and test equipment
- Collaborate with required stakeholders in the receive inspection function and across functions ensuring incoming materials and components meet defined specifications and regulatory requirements.
- 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.
- Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
- Participate in preparing / critically reviewing/approving NCMRs/ Investigations, providing QA technical direction and solutions as appropriate.
- Ensures effective product control measures in the event of issues being noted.
- 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.
- Supporting internal and external audits (MDR/MDSAP/FDA etc).
Key Skills & Experience
- We are looking for a qualified person with Level 8 Degree in Engineering / Science or related discipline and desirably with minimum 2 years’ relevant experience in a highly regulated industry.
- You are a dynamic team player and leader and can work effectively and proactively on cross-functional teams with a high level of enthusiasm and motivation.
- Good communication, organizational, presentation and leadership skills are desirable.
- Ability to work independently to plan and schedule own activities necessary
- to meet timelines highly desirable.
- Demonstrated critical thinking skills with focus on improved system
- performance outcomes and positive business impact
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