Quality Engineer I

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, we offer an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Benefits

• 401K Match: Save for retirement with the company's help.
• Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.
• Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.
• Corporate Events: We celebrate success as a team, because only together can we achieve our goals.
• Comprehensive benefits package including medical, dental, and vision coverage, retirement savings with company match, and paid time-off.

Pay

The expected salary range for this position is $65,000 to $75,000 annually, depending on skills, experience, and qualifications.

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, and customer satisfaction.
• 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.
• Assure 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.
• Identify and highlight any problem issues associated with quality; provide input for solutions to problems identified.
• Perform/lead the investigation of root cause and determination of corrective and preventive actions relating to NCMRs and CAPAs.
• Interface 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, and best quality practices.
• Participate and support safety and lean/continuous improvement initiatives.

Requirements

• 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.

Candidates must be legally authorized to work in the United States without current or future visa sponsorship. Location: Beverly, MA (On-Site).