Job Description

The Design Quality Engineer II provides Design Quality Engineering support to ensure the successful development of Cooper products and ongoing operational support, applying knowledge of design control principles and quality engineering techniques to support development efforts and address quality-related challenges. This role is responsible for ensuring products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer expectations, and reviews and evaluates scientific and technical data related to product development and testing, contributing to problem-solving activities for product and process improvements, while collaborating with cross-functional teams and providing guidance when appropriate.

• Quality Representation
• 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.
• Supplier Engagement
• 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.
• CAPAs/Non conformances
• 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.
• Design
• Participate in design reviews to evaluate designs and provide quality-related feedback.
• 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.
• V&V
• 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.
• Risk
• Identifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks.
• Process Improvement
• Identifies and contributes to improvements across all cross functional departments.
• Promotes continuous improvement in design control activities and use of quality tools with design team and other departments.
• Regulatory
• 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.
• Perform other duties as assigned.
• Travel:
• This position may require 0-5% domestic and/or international travel.

Qualifications

Knowledge, Skills and Abilities:

• 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.

Work Environment:

• Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
• Occasionally lift to 35 pounds.

Experience:

• 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.

Education:

• Bachelor’s Degree or higher in Science or Engineering (or related field).