Quality Engineer II

Freudenberg Medical; Beverly (MA); On-site; USD 87,000 - 105,000; Full time

Benefits offered by this job

401K match

Diversity & Inclusion

Personal development

Sustainability & social commitment

Corporate events

Job summary

Freudenberg Medical LLC in Beverly, MA is seeking a Quality Engineer II to apply quality standards across development, qualification and manufacturing of medical devices. You will lead analyses, audits and NPI quality activities to ensure regulatory compliance.

Join a global CDMO with strong focus on ISO 13485, GMP and 21 CFR 820, using MSA, FMEA and DOE tools to drive continuous improvement. Expect collaboration across engineering, operations and suppliers in a fast-paced environment.

Qualifications

• Bachelors degree in Engineering, Chemistry, Biology, or related field.
• 3+ years experience in Medical Device or a related regulated industry.
• Strong verbal and written communication across cross-functional teams.
• Knowledge of ISO 13485 and GMP, plus 21 CFR 820 (US).

Responsibilities

• Apply quality standards to support development, qualification and manufacturing of products to meet internal and external requirements.
• Apply statistical tools to analyze data, drive acceptance decisions, improve process capability and support continuous improvement and lean initiatives.
• Lead Measurement System Analysis (MSA) and supporting product acceptance activities.
• Collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers to assess, document and test change items.
• Create Master Validation Plan, validation protocols and reports (IQ/OQ/PQ) and risk management plans.
• Lead resolution of nonconformances, CAPAs, and quality issues for assigned projects.
• Support supplier quality activities, audits, and supplier qualification.
• Participate in internal and external audits and provide guidance to technicians.

Skills

Quality Assurance

Medical Devices

Statistical Methods

DOE

FMEA

ISO 13485

GMP Principles

Audits

MSA

GD&T

Metrology

Education

Bachelors degree in Engineering

Chemistry or related field

Tools

Micro-Vu

Keyence

Job description

Working at Freudenberg: \"We will wow your world!\" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

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, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

401K Match: Save for retirement with the company's help.

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.

Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.

Corporate Events: We celebrate success as a team, because only together can we achieve our goals.

*Candidates must be legally authorized to work in the United States without current or future visa sponsorship*

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off. Additional details will be shared during the recruitment process.

Beverly, MA

On-Site

Freudenberg Medical LLC

payments The expected salary range for this position is $87,000 to $105,000 annually, depending on skills, experience, and qualifications.

You support our team as

Quality Engineer II

Responsibilities

• Apply quality standards to support the development, qualification and manufacturing of products to meet internal and external requirements.
• Apply statistical tools to analyze data, drive acceptance decisions, improve process capability, and support continuous improvement and lean initiatives.
• Lead Measurement System Analysis (MSA) and supporting product acceptance activities.
• Support and collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers to ensure all change related items are adequately assessed, documented and tested as required.
• Create Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design reviews deliverables, risk management plan, ensure sound start-up of new processes and equipment and development of all quality related documentation.
• Lead resolution of nonconformances, complaints, CAPAs, etc. to resolve quality issues for assigned projects.
• Support supplier quality activities such as supplier selection, qualification, documentation, audits, etc. (QA in FM COS would not oversee, may participate).
• Participate in and occasionally lead internal and external audit.
• Provide guidance to technicians ensuring effective daily support for ongoing tasks.
• Lead New Product Introduction (NPI) Quality Activities and design transfer activities, including design verification, process validation (IQ/OQ/PQ), risk management (FMEA), and compliance with regulatory standards.

Qualifications

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
• 3+ years' experience in Medical Device or a related regulated industry.
• Strong verbal and written communication skills with the ability to effectively collaborate across cross-functional teams, including Quality, Engineering, Operations, and customers, to drive problem-solving and continuous improvement initiatives.
• Understanding of statistical methods, process control, internal/external audits, and the use of quality tools such as Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), Control Plan, MSA, SPC, as well as GD&T and fixturing.
• Demonstrated experience in metrology and quality inspection within a manufacturing environment, including Micro-Vu and Keyence measurement systems.
• Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills.
• Understanding of ISO standards, particularly ISO 13485, ISO 14001, ISO 14971.
• Knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States).

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.