Senior Quality Engineer - Sterilization

Manpower Engineering • Full-time • Eagan, MN, MN, United States • 1d ago

Manpower Engineering is partnering with a leader in medical device manufacturing for a Senior Quality Engineer.

Job Title: Senior Quality Engineer
Location: Eagan, MN (1 remote day per week)
Pay: $100,000 - $140,000 + (DOE)
Duration: Direct Hire

Job Function Summary:

We are seeking a Quality Engineer with experience in EtO and/or Gamma sterilization to support quality, regulatory, engineering, and manufacturing activities. This role will manage key quality system processes, support sterile product release, and ensure ongoing compliance with sterilization standards.

Primary Duties and Responsibilities:
Quality System & Compliance

Follow all regulations, standards, procedures, and work instructions defined in the Quality System Manual.
Review, investigate, and maintain the Complaint system, including documentation and closure activities.
Initiate, investigate, and document CAPAs, ensuring timely completion and risk‑appropriate actions.
Update or create procedures, work instructions, forms, and labels to support quality, manufacturing, and engineering activities.
Perform internal, supplier, and design history file audits.
Support inspections and audits conducted by FDA, Notified Bodies, OSHA, and others.
Lead or support customer audits as required.

Sterilization (EtO / Gamma) Responsibilities

Review and release sterile product, ensuring compliance with sterilization specifications and documentation requirements.
Review and analyze sterilization batch records (EtO and/or Gamma) for completeness and conformity.
Support sterilization validation and re‑qualification activities, including protocol review, data analysis, and reporting.
Collaborate with sterilization vendors to address nonconformances, deviations, environmental excursions, and cycle performance issues.
Maintain sterilization-related technical files, including biological indicators, dose audits, residual testing (for EtO), and dose mapping studies (for Gamma).
Ensure compliance with sterilization standards (e.g., ISO 11135 for EtO, ISO 11137 for Gamma).
Support risk assessments related to sterilization processes, bioburden changes, material compatibility, and packaging integrity.

Supplier & Documentation Support

Support supplier performance management and sourcing projects.
Maintain technical documentation including clinical evaluation reports, essential requirements, usability engineering reports, risk management files, and verification/validation reports.
Support Documentation Coordinator and Quality Inspector with document changes, training, incoming inspection, in‑process inspection, label inspection, and nonconforming material activities.
Assign and review deviations, ensuring traceable and compliant resolution.
Assist with maintaining agency listings and annual registrations.

Requirements:

 Bachelor’s Degree in Engineering preferred with 0–2+ years of experience in manufacturing; OR without a degree, minimum 3 years of experience in the medical device industry with demonstrated technical aptitude.
 Ability to learn and apply technology to company products and processes.
 Software proficiency in Microsoft Office, Adobe Acrobat, and Visio.
 Understanding of FDA 21 CFR 820, ISO 13485, MDSAP, Good Documentation Practices, and ISO 14971 preferred.
 Experience with sterilization processes (EtO and/or Gamma), sterilization documentation, sterile product release, or sterilization vendors is strongly preferred.
 Excellent verbal and written communication skills in English.
 Strong organizational skills and attention to detail.

Preferred Skills & Abilities:

 Knowledge of drafting standards and drafting software (SolidWorks, AutoCAD).
 Experience with eQMS, labeling software, and ERP systems.
 Analytical, troubleshooting, and problem‑solving skills.
 Certified Quality Engineer (CQE) or related training.
 Familiarity with sterilization standards: ISO 11135 (EtO), ISO 11137 (Gamma), bioburden testing, sterility assurance, or dose audits.

Benefits:

We offer a full complement of benefits including health, dental, vision, life insurance, 401(k) and generous PTO. Come work for a growing company that offers a fun, collaborative environment with work-family balance.
Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

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