Senior Supplier Quality Engineer - Manufacturing Plant Raw Materials
- Mishawaka, IN
Senior Supplier Quality Engineers are primarily responsible for all quality related aspects of raw material entering the plant. This includes day to day support of the manufacturing line, problems that occur, and non-conformance that may be generated. The role works closely with the manufacturing and engineering teams to assure compliance with all appropriate regulations and specifications. Prompt responsiveness is a requirement to avoid downtime.
Major tasks and responsibilities:
Support design transfer of new production coming into the facility, including raw material specification development, supplier audits and supplier monitoring/qualification, and development of incoming inspection processes.
Interact with multiple functions across sites including Engineering, Manufacturing, Technical Operations, and Regulatory Compliance.
• Support Manufacturing
o Provide quality engineering help w/ mfg. line problem resolution
o Drive process control & monitoring improvement
o Drive manufacturing process improvement activities to improve outgoing product quality, e.g. scrap reduction, SPC, improved test methods...etc.
o Support Process Validation activities
o Maintain mfg. compliance with regulatory requirements
o Provide operator training for new testing requirements
o Primary point to resolve QNs
• Test and Inspection
o "Own" all inspection and test requirements from incoming inspection to in-process testing to finished product testing.
• Ensure statistical valid sampling plans at all phases of operations.
• Ensure test & inspection methods are properly validated
• Ensure that test & inspection methods address Critical to Quality requirements from the dFMEA and pFMEA requirements
• Develop and implement improved test & inspection procedures, instruments, and methods.
• Develop and maintain Process Control & Monitoring Plans & Programs
o Every key manufacturing process should have a robust Process Control & Monitoring Plan that is driven as an output from the process validation.
o Continual monitoring of process controls to drive improvement.
• Supplier Quality
o Ensure that the quality of supplied materials is maintained and meets specification requirements
o Perform supplier quality audits as assigned
o Drive supplier corrective actions to resolution
• Audit Management
o Serve as Validation SME during audits
o Serve as test & inspection SME during audits
• Manufacturing Regulatory Compliance
• CAPA owners.
Preferred Bachelors Science - Industrial Engineering. Also acceptable with equivalent experience: Other engineering or science degree.
Seeking immunoassay experience with microfluidics, protein chemistry, and ELISA.
5-10 years' experience in the medical device/pharmaceutical industry with background in supplier quality. Knowledgeable of all industry regulations and requirements.
Process Control Technology experience is helpful.
Statistical knowledge and Design of Experiments experience.
Strong procedure development/technical writing skills.
Value Stream Mapping/Lean experience is helpful.
Strong communications background, both written and verbal.
ASQC Certifications helpful.
Other characteristics of the successful candidate:
• Very organized, detail-oriented
• Highly self-motivated
• Able to work independently
• Excellent analytical, communication, writing, and problem-solving skills
• Effective and influential in his/her interactions in team-based assignments
• Able to work well with personnel from different departments, and experience levels
• Ability for potential international travel from time to time.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.
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