Senior Design Assurance Engineer - Medical Device

Working at Freudenberg: We will wow your world!

Responsibilities:

• Lead the creation, documentation, maintenance, and control of Quality System Plans and Risk Management Plans with the approval of both the internal and client project teams and in accordance with applicable corporate procedures.
• Develop, maintain, execute, and control Component Validation Plans and external supplier qualifications during the product development lifecycle.
• Lead design verification / validation activities including protocol and report writing.
• Initiate and lead the resolution of non-conformances / CAPAs.
• Lead the creation and execution of test methods and test method validation plans in support of component, design, and process verification activities.
• Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
• Provide support to project teams in the compliance of ISO13485, MDD / MDR, QSR, JPAL, and any other applicable standards or requirements.
• Support and/or perform internal audits of the quality system and Design History Files (DHFs).
• Facilitate client personnel in performance of quality systems audits related to a particular project.
• Work collaboratively with engineers and other personnel that are assigned to the product development project team.
• Provide support to manufacturing quality engineering for changes made to quality system documentation of product projects transferred to sustaining manufacturing.
• Assist in the identification and selection of outside suppliers and consultants.
• Collaborate on process characterization, experimentation, optimization and qualifications.
• Assist in the creation and maintenance of credible project schedules.
• Provide coaching and guidance regarding project tasks to other associates.

Qualifications:

• BS degree in engineering or other technical/scientific discipline.
• Minimum 7 years experience in quality related product development roles
• Minimum 5 years experience in medical device industry.
• Experienced in quality systems (ISO13485, ISO9000 and/or QSR)
• Close visual acuity to perform activity exp. Small parts, operation of machines like visual measurement systems (Microviews or CMM)
• CQE, CQA (ratings), preferred

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC