Quality Engineer I

Freudenberg; Beverly (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Freudenberg is seeking a Quality Engineer in the United States to support development, qualification and manufacturing of medical devices. The role emphasizes quality system compliance, statistical methods, and risk management across ISO standards and regulatory requirements including 21 CFR 820.

The position requires a 0–3 year background in a regulated environment, with experience in DOE, FMEA, MSA, SPC and GD&T. Join a global technology group focused on quality and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology or related field.
• 0–3 years’ experience in Medical Device or related regulated industry.
• Knowledge of statistical methods, process control and quality tools (DOE, FMEA, Control Plan, MSA, SPC, GD&T).
• Experience with formal problem-solving methodologies and critical thinking.
• Understanding of ISO 13485, ISO 14001, ISO 14971 and GMP principles.
• Familiarity with design controls to align development, validation and verification with requirements.

Responsibilities

• Understand quality system requirements to support development, qualification and manufacturing.
• Utilize statistical analysis tools to support the project team.
• Support creation of Master Validation Plan, validation protocols and reports (IQ/OQ/PQ).
• Assist in and may lead handling nonconformances, complaints, CAPAs, etc.
• Support internal and external audits, ensuring quality system compliance.
• Support MSA including Gage R&R and method validations.

Skills

Quality systems

Statistical analysis

Problem solving

DOE

FMEA

Gage R&R

SPC

Documentation

Education

Bachelor's degree in Engineering

Tools

Gage R&R

DOE

FMEA

SPC

MSA

Job description

Working at Freudenberg: We will wow your world!

Responsibilities:

• Understand quality system requirements to support the development, qualification and manufacturing of products to meet internal and external requirements.
• Utilize statistical analysis tools to support project team.
• Support creation of Master Validation Plan, validation protocols and reports (IQ/OQ/PQ), quality design reviews deliverables, risk management plan, and all quality related documentation.
• Assist in and may lead supporting nonconformances, complaints, CAPAs, etc. to resolve quality issues.
• Support internal and external audits, ensuring quality system compliance.
• Support Measurement System Analysis (MSA), including Gage R&R, test method validations.

Qualifications:

• Bachelor's/University degree in Engineering, Chemistry, Biology, or related science/technical field.
• 0-3 years’ experience in Medical Device or a related regulated industry.
• Knowledge of statistical methods, process control, 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 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).
• Familiarity with design control processes to ensure that design/development, validation, and verification processes align with intended use and performance criteria.

Compensation for this position will be determined by the candidate's qualifications, experience, education, and overall alignment with the role's responsibilities.

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

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.