Quality Engineer II

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

Job summary

Freudenberg Medical LLC seeks a Quality Assurance professional to apply quality standards across development and manufacturing of medical devices. You will lead MSAs, audits, and continuous improvement efforts, collaborating with engineering, operations, regulatory, and suppliers to ensure robust quality documentation and change control.

The role emphasizes leading NPI quality activities, design transfer, and risk management, with a focus on ISO 13485, 21 CFR 820, and GMP compliance in a

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related field.
• 3+ years' experience in Medical Device or related regulated industry.
• Strong communication and cross-functional collaboration.
• Experience with ISO 13485 and GMP in medical device manufacturing.
• Knowledge of DOE, FMEA, Control Plan, MSA, SPC, GD&T.

Responsibilities

• Apply quality standards to support product development, qualification and manufacturing.
• Use statistical tools to analyze data, drive acceptance decisions, improve process capability.
• Lead MSA and product acceptance activities.
• Collaborate cross-functionally with engineering, operations, regulatory, customers and suppliers on change assessments.
• Create Master Validation Plans, IQ/OQ/PQ protocols and reports; risk management.
• Lead resolution of nonconformances, CAPAs, and quality issue resolution.
• Support supplier quality activities and participate in audits.
• Lead NPI Quality Activities and design transfer, including FMEA and regulatory compliance.

Skills

Statistical methods

Cross-functional collaboration

Quality systems

Problem solving

Documentation

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related field

Tools

Design of Experiments (DOE)

FMEA

Control Plan

MSA

SPC

GD&T

Fixturing

Micro-Vu

Keyence

Job description

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).

Salary

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

Equal Opportunity

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.

Company Culture

Freudenberg Medical LLC Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly.

And these are just three examples from thousands of our applications.

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 51,000 employees a networked and diverse environment where everyone can thrive individually.

Be surprised and experience your own wow moments.