DESIGN QUALITY ENGINEER LEAD OR MANAGER
Detail-oriented and collaborative member of Quality Team at PGDx. The primary responsibility will be to represent the Design Quality team in ensuring an effective design, development and transfer process that adheres to applicable FDA regulations, ISO 13485:2016 and other governing regulations applicable to PGDx. Provides quality support for new product introductions and ongoing projects throughout of product development lifecycle.
- Develop and administer quality design program components.
- Provide technical input to ensure the design, development and transfer activities with in Product development are adequate to transfer new IVD products to manufacturing.
- Perform a review of design projects and design control procedural deliverable requirements.
- Assist in developing design verification and validation plans, test methods and data analysis associated with product development.
- Participate in risk assessments, risk mitigation strategies and risk management plans, provide review/approval as needed.
- Provide design control lifecycle, procedure and policy training as necessary.
- Provide technical input into the development and execution of process validation activities.
- Provide technical assistance in the development of PDGx’s Quality Management System documentation to support the company’s IVD products.
- Support product design related investigation of quality events such as nonconformities, CAPAs, customer complaints, etc.
- Serves as Quality lead on design change control submissions.
- Conducts DHF audits of pipelines throughout the development lifecycle.
- Provide support and assistance during regulatory or partner audits, as appropriate and as directed by supervisor and the Management Representative.
- Other duties as assigned
REQUIRED EDUCATION AND EXPERIENCE:
- Bachelor’s Degree in Engineering or Science
- Minimum of 3-5 years in medical device or IVD products manufacturing within Quality.
- Strong knowledge in QSR/ISO 13485:2016 Design Control requirements
- Experienced in IVD products or NGS
- Strong analytical, organizational, communication, and interpersonal skills are required
- Must be assertive and courageous in ability to share differing viewpoints and perspectives
- Critical thinking ability and attention to detail
- Effective technical writing ability and verbal communications skills
- Computer skills including MS office