Design Quality Engineer II

Responsibilities

• Actively represent Quality function on product/process development teams.
• Support engineering teams to ensure design control requirements are met effectively, including design verification, validation, specifications, procedures, risk management, and design reviews.
• Support supplier tooling activities to help ensure components are qualified on time, including use of PPAP tools.
• Participate in supplier selection activities and specification reviews to help ensure purchased components meet requirements.
• Collaborate with Engineering to define quality characteristics and inspection plans for components, subassemblies, and finished devices.
• Participate in investigations of product and process issues; contribute to root cause analysis and corrective actions.
• Support evaluation and disposition of nonconforming materials used in development, pilot, or clinical builds in accordance with quality system requirements.
• Contribute to early stages of product development, including prototype evaluation, testing, and cross-functional collaboration.
• Provide input to design and manufacturing documentation (e.g., specifications, drawings, inspection procedures) to support manufacturability and testability.
• Contribute to development of design input requirements based on prior product knowledge, historical issues, and competitive insights.
• Support development of the master test plans (I.E. trace matrix, VMP….) that encompass design verification, design validation and process validation activities.
• Contribute to development, evaluation, and validation of product and process test methods.
• Review test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
• Identifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools.
• Promotes continuous improvement in design control activities and use of quality tools with design team and other departments.
• Comply with applicable FDA and international regulatory laws/standards and the Cooper’s Code of Conduct.
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
• Support Cooper as needed in FDA, notified body, internal, and other audits.

Qualifications

• Working knowledge of applicable laws and regulations.
• Intermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred.
• Ability to read and understand highly technical material.
• Proficient in reading and writing in English.
• Self-motivated and committed to a team approach.
• Effective oral, presentation and technical writing skills.
• Demonstrated ability to support decision making within quality engineering responsibilities.
• Experience collaborating with cross-functional teams in a medical device development environment.
• Strong analytical and problem-solving skills with acute attention to detail.
• Good communication and interpersonal skills.
• 3+ years experience in Quality Engineering in the medical device industry.
• Experience in related engineering areas, e.g. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.
• Experience in medical devices, with knowledge in women’s health preferred.
• Bachelor’s Degree or higher in Science or Engineering (or related field).