Quality Engineer II

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

Benefits offered by this job

Medical, dental, and vision coverage

Retirement savings with company match

Paid time-off

Job summary

Freudenberg Medical LLC seeks a Quality Engineer II in Beverly, MA, to support medical device manufacturing quality efforts. The role emphasizes robust problem solving, data-driven decisions, and cross-functional collaboration to improve processes and product quality.

The ideal candidate holds a technical degree and 3+ years in regulated medical device environments, with hands-on experience in metrology and quality tools. US work authorization is required for employment consideration.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related science/technical field.
• 3+ years of experience in Medical Device or related regulated industry.
• Strong verbal and written communication to collaborate across cross-functional teams.
• Understanding of ISO standards (13485, 14001, 14971) and GMP in medical device manufacturing.
• Experience with metrology/quality inspection (Micro-Vu, Keyence).
• Familiarity with DOE, FMEA, Control Plan, MSA, SPC; GD&T knowledge.
• Proven problem-solving, critical thinking, and deductive skills.

Skills

Statistical methods

Process control

Audits

Quality tools: DOE, FMEA, Control Plan

GD&T

Metrology & inspection (Micro-Vu/Key-"

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related science/technical 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 arrow_right

Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.

Personal Development

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

Sustainability & Social Commitment

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

Corporate Events

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.

location_on Beverly, MA

On-Site

trip_origin 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

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Qualifications arrow_right

• 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.