Sr. Engineer, Supplier Quality - Wayne, NJ
GetingeAbout the role
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
Executes Supplier Quality Processes with no oversight needed. Train other SQEs in Supplier Quality Processes. Maintain/Update Supplier Quality Processes as necessary. This position covers both CAHW and CADI businesses. Supplier Quality Processes include Supplier Selection and Management, Supplier Corrective Action Request, Supplier Initiated Change Request, Supplier Audit, and Getinge Part Approval Process.
Job Responsibilities and Essential Duties
- (80%) Lead Supplier Quality Projects, solving complex problems by driving cross-functional consensus in various SQ Processes including SSM, SCARs, SICRs, PPAPs, and Audits.
- Consistently demonstrate compliance to all GxPs and SQ processes.
- Coordinate (SME) one or more Supplier Quality Processes.
- Act as SME for Supplier Quality for external audits as needed.
- Support Supplier Development Activities by establishing good partnerships with suppliers, developing their technical capability to meet our specifications. Ability to translate insights into Supplier Process / Performance improvements.
- (10%) Mentors Level I and Level II Supplier Quality Engineers in best practices, industry trends, personal development journey, and communication skills.
- (5%) Compile / Report / Participate in supplier quality performance metric meetings. (Monthly, Management Review, Semi-Annual Performance Reviews)
- (2.5%) Achieve and maintain certifications:
- Lead Auditor Status – ISO13485 Lead Auditor Cert + ASQ CQA
- ASQ CQE
- (2.5%) Participate / Lead department Corrective Actions Preventive Action (CAPAs).
Minimum Requirements
- 5+ years’ experience in a medical device (capital goods with electromechanical components and/or disposables) manufacturing environment desired
- Minimum 5 years Supplier Quality Engineering experience desired.
- Supplier Auditing experience desired
- Certified Lead Auditor desired
- Up to 10% travel
Salary range: $110k - $125k
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