Supplier Quality Engineer

Manpower Engineering; Maple Grove (MN); Hybride; USD 58 000 - 73 000; Plein temps

Avantages offerts par ce poste

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care Flexible Spending账户

Résumé du poste

Manpower Engineering is partnering with a leader in the Medical Device industry for a Supplier Quality Engineer position in Maple Grove, MN. The role is hybrid and offers $42-$53 per hour on a 12+ month contract with potential to convert to permanent.

The candidate will lead remediation activities for CAPA-related supplier issues, interact cross-functionally with teams and CM SFMD suppliers, and ensure compliance with quality processes to uphold patient safety and product quality.

Qualifications

• Bachelor’s degree in engineering is required.
• 2–5 years of experience in a manufacturing environment.
• Ability to travel up to 15% of the time (Domestic travel possible).
• Problem solving abilities.
• Manufacturing experience.
• Validation experience.
• Change management experience.

Responsabilités

• Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve CM SFMD supplier’s process and inspection validations to statistical requirements.
• Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
• Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
• In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Connaissances

Problem solving

Manufacturing experience

Travel up to 15%

Formation

Bachelor’s degree in engineering

Outils

IQ/OQ/PQ/TMV

Description du poste

Manpower Engineering is partnering with a leader in the Medical Device industry for a Supplier Quality Engineer.

Job Title: Supplier Quality Engineer

Location: Maple Grove, MN (HYBRID)

Pay: $42 - $53/hour

Duration: 12+ month contract (potential to convert to perm)

Job Description:

This Supplier Engineer will be responsible for the remediation activities identified by CAPA 7720 for contract manufactured sourced finished medical device product. This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with team members and CM SFMD suppliers to execute deliverables according to business needs.

Key Responsibilities:

• Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve CM SFMD supplier’s process and inspection validations to statistical requirements.
• Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
• Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
• In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Required Qualifications:

• Bachelor’s degree in engineering is required!
• 2-5 years of experience in a manufacturing environment.
• Ability to travel up to 15% of the time. (Domestic possible.)
• Problem solving abilities
• Manufacturing. experience
• Validation experience
• Change management experience

Preferred qualifications:

• Experience working with suppliers or in supply chain management.
• Experience working in the Medical Device Field.
• Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
• Excellent communication and project management skills.
• Self-driven and self-motivated to learn and apply knowledge to produce results.
• Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.

Benefits:

Upon completion of waiting period, consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long-Term Disability Insurance
• Accrued Sick Pay
• 401(k)

About ManpowerGroup, Parent Company of:

Manpower, Experis and Talent Solutions

Experis® is a global leader in technology services and part of the ManpowerGroup® (NYSE: MAN) family of brands. We connect skilled technology professionals with meaningful opportunities where they can grow their careers, expand their expertise and make a real impact. Guided by the belief that it takes Human Ingenuity to unlock the true potential of technology, Experis helps people gain experience with leading organizations, build sought‑after skills and take the next step toward a brighter future. Backed by ManpowerGroup's 75+ years of workforce expertise and global reach across more than 70 countries and territories, Experis brings the scale, insight and opportunity to help people and businesses thrive. ManpowerGroup is consistently recognized for its commitment to inclusion, ethics and responsible business, including being named one of the World's Most Ethical Companies. Learn more at Experis.com.