MilliporeSigma has an exciting new opportunity for a Quality Engineer to join their team! This position is a temp to hire position and we are looking for an exceptional individual with ISO knowledge and ability to interact with all levels of the organization.
Seeking a Quality Engineer to help lead implementation and promote QMS adoption. Be on the ground floor as our site works to meet requirements for ISO 9001:2015 Certification. Work at all levels of the organization (shop floor to senior leadership) to refine and develop site QMS.
Quality Engineer will assist with planning, implementing, and sustaining a site-wide quality management program. Candidate will own management of supplier quality, internal-audit, as well as product line support.
- Lead implementation of a site Supplier Quality Management program. Work with leadership to align with divisional requirements.
- Expand and formalize incoming quality inspection program (non-conformance disposition, return of material to suppliers, tracking supplier performance). Develop supplier quality plans using risk based assessments to determine inspection requirements and acceptance criteria.
- Lead implementation of a local site internal audit program. Train other local auditors. Audit local quality processes such as Document Control, Training, CAPA, Deviation, etc. to ensure site procedures are followed.
- Support site Quality Management System: Assist in the definition, implementation, and maintenance of quality processes and procedures supporting business and regulatory needs.
- Support Corrective and Preventative Action Program (CAPA) for assigned product family - Identify problems, establish effective corrective actions, and work to resolve problems.
- Generate monthly metrics for divisional and corporate leadership (for assigned product family).
Working hours: Monday through Friday, 8am to 5pm(can adjust as needed)
Skills & Abilities
- Working knowledge of ISO 9001 and/or ISO 13485 requirements
- Lead Auditor Experience (certification preferred)
- Experience validating production processes
- Positive "can-do" approach for implementing QMS
- Detail-oriented and a creative problem-solver.
- Strong relationship building skills.
- Ability to work independently, with minimal supervision
- Strong Microsoft Office computer skills, and experience working with data analysis problem solving tools.
- Excellent analytical skills. Able to use data to identify trends and understand problems.
Preferred Skills & Abilities
- Experience working as part of New Product Development core team.
- Experience hosting on-site 3rd Party audits (Customer, TUV, FDA).
- Experience validating production processes (FMEA, VVQ, DCP)
- Experience working in an electronic manufacturing environment
- Bill of Material (BOM) maintenance and review experience
Education and Experience:
- Bachelor of Science degree in life science or engineering
- 3-5 years experience as a manufacturing, quality or supplier quality engineer.
- Any combination of education and experience that provides the same expertise.
Salary: Depending on experience
Working Hours: Monday through Friday, daytime hours: 8am to 5pm (flexible hours can be adjusted on a case by case basis)
Interested? Please send updated resume to Rebecca.Ricksgers@external.emdmillipore.com or call me at 951-514-4501.
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