Job Information
ManpowerGroup Supplier Quality Engineer in Eagan, Minnesota
Manpower Engineering is partnering with a leader in medical device manufacturing for a Supplier Quality Engineer.
Job Title: Supplier Quality Engineer
Location: Eagan, MN (1 remote day per week)
Pay: $90,000 - $125,000 + (DOE)
Duration: Direct Hire
Job Function Summary:
The Quality Engineer will provide support to Quality, Regulatory, Engineering, Manufacturing, Sales, Marketing, Accounting and Customer Service. This position will be involved in processing complaints, CAPA’s, document changes, maintaining the calibration system, performing audits, maintaining technical files, supplier performance management and other quality and regulatory duties as assigned.
Primary Duties and Responsibilities:
Follow all regulations, standards, procedures, and work instructions defined in the Quality System Manual
Maintain the Complaint system, including documenting, reviewing, investigating, and closing Complaints
Review, investigate and document CAPAs
Update or create procedures, work instructions, forms and labels using Word, Excel, etc. in support of quality, manufacturing, and engineering activities
Maintain the Calibration System
Review and release sterile product
Support clean room environment monitoring activities
Support supplier performance management programs and sourcing projects
Review document changes as assigned
Support the compilation of technical files including clinical evaluation reports, essential requirements, usability engineering reports, risk management files, verification, and validation etc.
Perform internal, supplier and design history file audits
Support Documentation Coordinator and Quality Inspector as needed (Document Change Order implementation, Training, In-coming Inspection, In-process Inspection, Label Inspection, Non-conforming Material Reports
Assign and review deviations
Support agency listings and annual registrations
Support inspections and audits performed by FDA, Notified Body, OSHA, other
Support / Lead Customer audits
Assist in compiling Design History Files
Support sourcing projects and the Approved Supplier List
Requirements:
Bachelor’s Degree in Engineering preferred with 0-2 years of experience in manufacturing. Without a degree: minimum of 3 years’ experience in medical device industry with technical aptitude.
Ability to apply learned technology to company products and processes
Software proficiency: Microsoft Office, Adobe Acrobat, Visio.
Understanding of FDA 21 CFR Regulations, ISO 13485, MDSAP, Good Documentation Practices, ISO 14971 preferred
Possess excellent verbal and written communication skills in English. Ability to read, write and speak English to communicate and execute internal Procedures, Drawings, Manufacturing Work Instructions (MWI), and other duties.
Preferred Skills & Abilities:
Knowledge of drafting standards and drafting software (Solidworks, AutoCad)
Experience with eQMS and Labeling software, and ERP systems
Basic analytical, troubleshooting, and problem-solving skills.
Certified quality engineer or relevant training
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.
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.