Quality Engineer (Electromechanical Medical Device)
Quality Engineer (Electromechanical Medical Device)
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Salary Not Disclosed
1 Vacancy
Job Description
Key Responsibilities
- Responsible for Supplier Quality Management cycle.
- Primary contact with suppliers on all quality related issues during both supplier maintenance & supplier selection process.
- Oversee supplier quality management activities & continuous improvement initiatives with suppliers.
- Plan & lead required supplier audits.
- Establish & maintains supplier quality metrics scorecards & trending.
- Generate quality plans & define risk control measures for continuous improvement.
- Conduct Design of Experiments (DOE) & Process Characterization for process optimization &/or improvement by conducting analyses using statistical techniques including Gage Repeatability & Reproducibility (Gage R&R) Tolerance intervals & Process Capability assessments with Cp or Cpk Lead or support design activities including design verification validation specification setting & justification test method development usability engineering & risk management.
- Plan & conduct product & process verification & validation including Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) & Process Performance Qualification (PPQ).
Qualifications :
Education & Experience
Must possess a Bachelors degree in engineering (mechanical industrial chemical electrical) or
other technical discipline. Must have 1 year of quality engineering work experience in FDA regulated medical device manufacturing environment(s).
If experience required must have 1 year of related work experience:
- conducting analyses using statistical techniques including Gage Repeatability & Reproducibility Tolerance intervals & Process Capability assessments;
- executing Installation Qualification Operational Qualification Performance Qualification & Process Performance Qualification;
- supporting quality system management process controls & Corrective Actions/Preventative Action systems by applying essential quality tools & statistical technique including: 8D 5-Whys 6M SPC DoE & Fishbone diagram;
- reading & interpreting mechanical drawings & GD&T;
- performing daily assigned tasks in compliance with FDAs Quality System Regulation (QSR) ISO 13485 ISO 14971 MDR & MDSAP;
- performing all tasks according to medical device development life cycles manufacturing processes & GMP; &
- working in a cross-functional team in a multisite corporation preparing & delivering reports &/or presentations to scientific & business audiences including executive team both orally & in writing.
Work experience may be gained concurrently.
Additional Information :
Salary Range: $108393.48 - 122000.00 per year.
Apply online at resume to . Refer to Req ID: REF41154L
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
