The posting
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.
Responsibilities
- Quality RepresentationActively 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 EngagementSupport 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 conformancesParticipate 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&VSupport 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.
- RiskIdentifies 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 ImprovementIdentifies 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.
- RegulatoryComply 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
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).
Our Benefits:
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $78,420 - $100,000.00 annually. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.
