About the Role
The Quality Engineer is responsible for supporting all quality engineering activities to support the product life cycle, from development of new products (NPD) from concept through commercialization, through sustaining changes, as part of a cross-functional development team.
Key Activities
Ensure successful transfer of new products to the production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
Assist in the creation of verification and validation test plans, protocols, and reports. Oversee testing and analysis for standards and product requirements compliance.
Ensure that product development projects and changes to existing products are conducted in compliance with regulatory authorities including but not limited to the FDA and Notified Body.
Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
Participate in cross-functional teams to develop product risk management file (risk management plan, risk assessments, dFMEA, and risk management report).
Ability to manage multiple projects simultaneously without much supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members and other support personnel and solving project-related conflicts and issues.
Preferred Skills
Good verbal and written communication skills, including protocol / report development and technical presentations.
Experience in Risk Management ISO 14971
Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis.
Experience of verification/validation test plan development and root cause failure analysis.
Education and Experience
BS in Engineering or Life Sciences or related field. Candidates with an Associate's degree in Engineering Technology or a related technical discipline, combined with relevant manufacturing or medical device quality experience, will also be considered.
Minimum of 2+ years of medical device experience preferred.
Experience in Lean and Six Sigma methodologies.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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