
Supplier Quality Engineer – III
KARL STORZ
full-time
Posted on:
Location Type: Office
Location: Charlton • Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $89,000 - $115,700 per year
Job Level
Mid-LevelSenior
About the role
- Provide technical support for supply chain management.
- Works closely with Purchasing and KARL STORZ suppliers to develop and implement product requirements and associated process controls.
- Implements and uses statistical analysis techniques to monitor supplier performance, spearheading any required actions in a continual improvement environment.
- Assists in the activities to move to and sustain Lean Manufacturing.
- Technical lead in the identification, development, and qualification of suppliers.
- Technical lead in the maintenance and improvement activities associated with supplier certification and supply chain management.
- Works closely with critical suppliers to review and implement statistical analysis techniques to ensure supplier process stability and capability and to monitor the performance of the supplier.
- Works closely with procurement and manufacturing to implement lean techniques in the production, receipt, and consumption of supplied products within KARL STORZ operations.
- Technical lead in identifying, developing, and approving results of any required supplier validation and re-validation protocols on new or changed supplier processes/products.
- Performs system, product, and process audits of suppliers to assist in developing suppliers and assuring continual improvement.
- Assists in the identification of critical dimensions and features of supplied products.
- Analyzes trends in product/process performance from new product development through service, coordinating any required root cause analysis and corrective action associated with suppliers.
- Assists in the review and disposition of non-conforming material received from suppliers.
- Support failure review activities.
- Attend MRB meetings as required.
- Regular attendance is an essential job function.
- Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of KARL STORZ products and services.
- Performs system, process, and product assessments within KARL STORZ, spearheading any required follow-on actions.
- Assists in sustaining manufacturing and service processes.
- Performs other related duties as assigned by supervisor.
Requirements
- Bachelor’s Degree in an Engineering, Math, or related discipline with 4-8 years of experience in manufacturing or Masters in an Engineering, Math, or related discipline with 3-6 years of experience in manufacturing.
- Maintaining an ASQ certification as a Quality Engineer, Six Sigma Green Belt, or Six Sigma Black Belt will be considered in place of a Bachelor’s degree.
- Knowledge of medical device quality system regulations and standards (e.g., U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001).
- Knowledgeable in GD&T and can explain clearly to Suppliers who don’t understand.
- Working knowledge of Lean Six Sigma principles and Supply Chain Management.
- Working knowledge of statistical analysis techniques such as, but not limited to: SPC, DOE, pFMEA, and Measurement System Analysis.
- Proficient in utilizing common “off the shelf” mechanical measuring and electronic test equipment.
- Able to read and comprehend engineering drawings and specification sheets.
- Demonstrated ability to successfully develop processes, define process controls, and validate process and product performance.
- Demonstrated ability to successfully manage multiple assignments and projects.
- Demonstrated ability to successfully lead teams in a consensus building effort towards a defined goal.
Benefits
- Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
- 3 weeks vacation, 11 holidays plus paid sick time
- Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
- 401(k) retirement savings plan providing a match of 60% of the employee’s first 6% contribution (up to IRS limits)
- Section 125 Flexible Spending Accounts
- Life, STD, LTD & LTC Insurance
- We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
- Fitness reimbursement of up to $200 annually
- And much more!
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical analysis techniquesLean Manufacturingsupply chain managementGD&TLean Six SigmaSPCDOEpFMEAMeasurement System Analysisprocess validation
Soft skills
team leadershipproject managementcommunicationproblem-solvingconsensus buildinganalytical thinkingattention to detailmulti-taskingcontinuous improvementroot cause analysis
Certifications
Bachelor’s Degree in EngineeringMaster’s Degree in EngineeringASQ Quality EngineerSix Sigma Green BeltSix Sigma Black Belt