We have an outstanding career opportunity for aQuality Engineer to join a leading Company located in theCoon Rapids, MN surrounding area.

Salary:

$80k - $100k The Quality Engineer is responsible for developing new processes/products, validating new equipment and technology, assisting production with continuous improvement on the shop floor, managing customer complaints, and handling

CAPA/NCR

activities. This role also involves leading change requests with customers and ensuring compliance with ISO 13485, FDA, and other applicable standards. The Quality Engineer collaborates closely with QA Technicians and Quality Inspectors (QAR).

Job Responsibilities:

+

Process and Product Development:

+ Develop new processes/products and revise existing ones.

+ Create and update project-specific quality plans , ensuring adherence to customer requirements.

+ Work as part of a cross-functional team.

+ Develop methods to measure products to ensure they meet quality standards.

+ Troubleshoot measurement methods and equipment to ensure accuracy and reliability. +

Validation:

+ Lead validation of new products and technology (IQ, OQ, PQ).

+ Act as QA lead for equipment validation. +

Customer and Supplier Interface:

+ Collaborate with customers and suppliers on new product processes.

+ Lead customer complaints and supplier SCAR management. +

Statistical Analysis:

+ Compile and analyze statistical data to assess process capabilities.

+ Conduct PFMEA, GR&R, and SPC studies. +

Quality System Documentation:

+ Create and maintain quality system documentation, including quality plans, inspection and control plans, and work instructions. +

NCR and CAPA Management:

+ Manage

NCR , CAPA

, and customer complaints from creation to closure. + Use problem-solving tools and work as part of a cross-functional team. +

Change Management:

+ Lead changes in production , ensuring compliance with customer agreements, ISO standards, and internal requirements.

+ Prepare, submit, and follow change requests (SCR) with customers. +

Production Support:

+ Assist production in achieving APU objectives.

+ Generate quality KPIs for PSM2. +

Audits:

+ Perform internal and external audits. +

Secondary Responsibilities:

+

Backup Support:

+ Serve as backup for other QEs on customer or internal tasks as requested by the Director of Quality. +

Continuous Improvement:

+ Identify and support continuous improvement opportunities.

+ Participate in LEAP workshops. +

Training:

+ Contribute to employee training. +

Other Duties:

+ Perform other duties as assigned. Benefits offered vary by contract. Depending on your temporary assignment, benefits may include direct deposit, free career counseling services, 401(k), select paid holidays, short-term disability insurance, skills training, employee referral bonus, and affordable medical coverage plan, and DailyPay (in some locations). For a full description of benefits available to you, be sure to talk with your recruiter. Military connected talent encouraged to apply. VEVRAA Federal Contractor / Request Priority Protected Veteran Referrals / Equal Opportunity Employer / Veterans / Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please visithttp://www.tadpgs.

com/candidate-privacy/orhttps:

//pdsdefense.com/candidate-privacy/ The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

+ The California Fair Chance Act

+ Los Angeles City Fair Chance Ordinance

+ Los Angeles County Fair Chance Ordinance for Employers

+ San Francisco Fair Chance Ordinance