Medical Device Quality Assurance Specialist

7 days ago


South Plainfield, New Jersey, United States Katalyst Healthcares and Life Sciences Full time
Company Overview:
Katalyst Healthcares and Life Sciences is a leading medical device manufacturer that develops innovative products to improve patient outcomes. We are committed to delivering high-quality products that meet or exceed regulatory requirements.

Job Description:
We are seeking an experienced Design Quality Engineer to support remediation activities surrounding risk management and design FMEAs as well as SFMEAs. As a key member of our team, you will be responsible for leading, conducting, and owning risk management activities including hazard analysis, system risk analysis, and various FMEAs. You will ensure compliance to ISO 14971 and implementation of risk management best practices, ensuring that design controls are compliant with all relevant regulations, and applying FDA and other regulatory knowledge and experience to risk and testing assessments.

This role's emphasis is on supporting remediation of existing risk management and design control activities. Additionally, the role may include supporting risk management and design control related procedure updates. Responsibilities will also include supporting design quality engineering activities in support of product development and life cycle processes, including design controls, quality planning, risk management assessments, design reviews, test method development and validation, design verification and validation test plans and reports.

This individual should have experience contributing to the design, development, and implementation of product assurance plans, providing feedback to corrective and preventative actions to engineering, manufacturing, service, and field operations, and supplier performance. They should also be comfortable working with manufacturing engineering to ensure necessary process controls are in place for initial product launch and significant design changes, reviewing and approving change requests and Engineering Change Orders (ECO) as needed.

Key Responsibilities:
  • Lead, conduct, and own risk management activities
  • Ensure compliance to ISO 14971 and risk management best practices
  • Apply FDA and other regulatory knowledge and experience to risk and testing assessments
  • SUPPORT design quality engineering activities in product development and life cycle processes


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