Quality Engineer I

Working at Freudenberg: We will wow your world!

Responsibilities

Performs all measures of quality planning for incoming and in-process inspections as well as final acceptance – Develop and support the generation of Flow charts, FMEAs and Control plans Handle multiple projects and tasks, from product inception through product launch and maintenance. Play an active role in the processes to ensure products meet quality standards consistent with internal quality policy.

Supports plant activities in process validation, process capability issues and customer issues, initiates corrective and preventive action, with an eye to increased capability, reduced inspection time/effort , customer satisfaction and supports Quality System implementation. Transition products from development to manufacturing by composing and/or reviewing protocols and reports for the IQ/OQ/PQ process Establish statistical standards of performance by providing support and expertise in Gage R&R, DOE, reliability strategy, and analytical problem solving techniques.

Establish manufacturing inspection, sampling and statistical process control methods and procedures to assure the quality of manufactured products. Assures compliance to in-house and external specifications and standards, such as GMPs, GDPs, ANSI and ISO regulations. Support customer and ISO audits for assigned projects and support internal audit programs as an auditor.

Identifies and highlights any problem issues associated with quality. Provides input for solutions to problems identified. Performs/leads with the investigation of root cause and determination of corrective and preventive actions relating to NCMRs and CAPAs Interfaces with manufacturing and engineering to resolve quality issues for new and existing product lines.

Help control the nonconforming product/MRB process. Draft reports, work instructions, and other technical documents. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support the schedule and day to day tasks for the quality department to ensure internal and external needs are met in a timely manner Provide training to in-house personnel regarding instructions and standards of work.

Train inspection personnel on entries and record utilizing, measurement equipment, SAP, best quality practices etc. Participate and support in safety and lean/continuous improvement initiatives.

Qualifications

Bachelor's Degree in Engineering or related field. Minimum of 3 years of experience as a Quality Engineer Minimum of 3 years of experience in a manufacturing environment of medical or health care products and knowledge of injection molding processes Certified Quality Engineer (CQE) and or Certified Quality Auditor (CQA) preferred.

Lean/Six Sigma certification preferred. Project management experience preferred. Experience with ERP systems such as SAP 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