Quality Engineer I

Summary

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions for medical device and pharmaceutical companies. The Quality Engineer I will support the development, qualification, and manufacturing of products to meet quality system requirements and assist in resolving quality issues through various quality-related documentation and audits.

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

Skills

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

Qualifications

Must Haves

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

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.
• Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.
• Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.
• Personal Development: We offer a variety of trainings to ensure you can develop in your career.
• We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off.