Supplier Quality Engineer II
Supplier Quality Engineer II
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Job Description
The Supplier Quality Engineer II (SQE) is responsible for managing the quality of products provided by suppliers and contractors to CONMED and ensuring compliance to regulations by ensuring adherence to proper purchasing controls including the procedures for supplier qualification part qualification nonconformance management supplier corrective actions and supplier performance monitoring.
The SQE II supports sourcing of purchased items through an assessment of supplier capabilities and the successful completion of component qualifications that verify manufacturing capabilities. During new product development activities the SQE provides guidance on inspection methods and works closely with Inspection services to conduct Measurement Systems Analysis (MSA) and establish correlation with the supplier. SQE also works closely with purchasing manufacturing and the supplier to facilitate issue resolution for non-conformances and to ensure effective root cause corrective actions are implemented to prevent recurrence.
Duties and Responsibilities:
Supports issue resolution for purchased items and provides risk assessment and final disposition of non-confirming product.
Supports development of new purchased products including specification requirements and risk documentation.
Facilitates and approves supplier component qualifications including process validations to verify implementation of acceptable inspection techniques manufacturing process controls and Quality System controls.
Works with supplier and receiving inspection to develop and correlate robust inspection methods and fixtures as required.
Creates and updates Receiving Inspection Plans.
Supports Supplier Change Requests and facilitates impact assessment and plan development.
Requests and verifies successful completion of First Article Inspections during part qualifications.
Manages/conducts supplier audits (on-site or desk) and verifies completion of identified supplier corrective actions (SCARs).
Maintains records for coordination of Quality System reporting.
Identifies and implements QS processes improvement opportunities.
Other duties to support Supplier Quality activities as required.
Requirements:
Bachelor degree in Engineering or related technical discipline
2 years of related experience in engineering field
Preferred Skills:
ASQ certifications (CQA CQE)
Knowledgeable of medical device Quality System Requirements and an understanding of compliance with FDA CFR 21 part 820 GMP and ISO 13485 preferred.
Ability to read and understand engineering drawings required. Understanding of GD&T specifications and how they translate to measurement methods.
Capable of implementing statistical methods and techniques for process controls and data analysis.
Understanding of the practical application and capabilities of various types of inspection equipment including hand tools (fixed gauges micrometers calipers) and programable touch and vision systems (CMM DVM) and similar equipment.
Experience and or training with DMAIC problem solving techniques preferred.
Understanding of various manufacturing processes including machining molding forming coatings and various surface treatments preferred.
0- 20% travel
This position is not open to employer based visa sponsorship.
This job posting is anticipated to close on August 15 2025. We may however extend this time period in which case the posting will remain available on . Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- Competitive compensation
- Excellent healthcare including medical dental vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by CONMED
- Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar with the potential for up to 7% per pay period
- Employee Stock Purchase Plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
Know someone at CONMED Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.
Colorado Residents: In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
If you feel you need a reasonable accommodation pursuant to the ADA you are encouraged to contact us at option #5.
Employment Type
Full-Time
