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Title: Manufacturing Engineer III
Location: Maple Grove MN (Hybrid)
Job Type: contract for 12 months initially with possibility of extensions
Position Summary:
- Hybrid - 3 days onsite (required onsite T, W, TH.) MG.
Job Title: Supplier Engineer III
About the role:
This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for Clients contract manufactured (CM) sourced finished medical device (SFMD) product. This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with Client team members and CM SFMD suppliers to execute deliverables according to business needs.
Responsibilities Include:
- Review, remediate, and approve CM SFMD suppliers process risk documentation (PFMEA) to newly defined criteria.
- Review, remediate, and approve CM SFMD suppliers process and inspection validations to Clients statistical requirements.
- Perform change management activities to remediate gaps found in CM SFMD Suppliers process risk documentation and process/inspection validations.
- Collaborate with CM SFMD suppliers and Client functional resources to complete all activities needed to approve suppliers 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.
- Quality Systems Duties and Responsibilities: Build Quality into all aspects of their work by maintaining compliance to all Quality System requirements.
Required Qualifications:
- Bachelors 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
- Mfg. 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.
- Strong bias for action and results oriented.
- 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.
Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.
Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit .
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
