Senior Quality Design Engineer
New Today
The role includes working with multidisciplinary teams to ensure medical device development and remediation activities are planned and executed in compliance with design control requirements of company quality management system, ISO, FDA, and other regulatory agencies. Additionally, this role has oversight of the development and maintenance of contact lens device history & risk management files for all assigned products.
The role will support marketed product changes and updates (MOB) and represent design quality on new product development and/or device maintenance of business (MOB) teams.
Responsibilities:
- Ensure project plans comply with FDA, EU MDR, and ISO design control requirements.
- Ensure projects adequately meet design, development, technology transfer, validation, and post launch requirements in accordance with the corporate product development process (PDP).
- Manage the documentation of product design control activities (i.e. DHFI, etc.)
- Manage product risk management requirements per ISO 14971.
- Review and approve equipment qualifications, product/process specifications, analytical method qualifications, development engineering protocols, validation strategies/protocols/reports, clinical trial material protocols & batch records, QCR's etc.
- Issue QA Product Release authorizations for new products
- Complete and provide risk management and/or complaint data updates to annual Product Quality Reviews (PQR), revisions to Design Risk Analysis, and input to Clinical Evaluation Reports.
- Support post launch design changes as required.
- Support internal and external audits as a design quality subject matter expert. This includes providing front room and/or back room support as required.
- Ensure project plans comply with FDA, EU MDR, and ISO design control requirements.
Qualifications:
- Minimum of BS in quality sciences or scientific/engineering discipline.
- Preference with Chemistry background.
- Minimum 4 years in medical device or pharmaceutical industry in Quality, R&D, Engineering or Laboratory environment
- Familiarity with relevant regulations and standards (i.e., FDA 21 CFR, EU MDD/MDR, ISO-13485, ISO-14971).
Any additional expertise in the below fields are highly preferred:
- Medical device product development.
- Risk management experience.
- Previous Compliant management, complaint review and corrective action.
- Quality experience in medical device or pharma industry.
- Knowledge of structured problem solving, six sigma, and lean tools.
9765601
- Location:
- Rochester
