Kestra Medical Technologies Inc.
Sr Supplier Quality Engineer
Kirkland, WA · Senior
No sponsorship$140k-$150kDetected 23 hours ago
Data AnalysisProject ManagementExcelSupply ChainProcess ImprovementElectrical EngineeringGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingLean Manufacturing
About the role
- Assesses, monitors, and ensures the continued adequacy and effectiveness of the quality system for the assigned supplier base.
- Reviews and approves inspection sampling plans for selection parts.
- Duties, responsibilities, and activities may change or new ones may be assigned at any time with or without notice.
Responsibilities
- Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a
- Leads new and existing supplier audits, selection, development, and supports supply chain team strategies
- Participates in design reviews with development teams and suppliers to ensure manufacturable designs and
- Manages supplier part/assembly qualifications using PFMEA/AQPQ/PPAP techniques
- Manages supplier process validation plans, and reports using IQ/OQ/PQ validation techniques
- Maintains supplier key performance indicators (KPIs) to support supplier score cards, and drive
- Drives supplier quality MRB dispositions, root cause determination, and 8D corrective actions/supplier
- Utilizes six-sigma and lean manufacturing techniques to lead continuous improvement of supplier
- Acts as supplier primary technical contact working both independently and in teams to support company
- Kestra maintains a drug free workplace and testing is a condition of employment.
Requirements
- Bachelor's degree in electrical engineering or material science, technical science or equivalent combination of
- 8+ years' directly relevant experience, with prior experience in a FDA/cGMP or regulated environment
- Working knowledge of PPAP and IQ/OQ/PQ validation techniques
- Deep expertise in high-level quality systems best practices
- Occasional lifting required, up to 20 pounds
- Frequent travel is required, 20%-30%
- Applicants must be eligible to work for any employer in the U.S.
- This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the
Nice to have
- 8+ years of experience in FDA/regulated environment
- Team leadership and project management experience
- Experienced with six-sigma and lean manufacturing techniques
- Direct experience working with injection molding, plastic film welding/bonding, over-molded cables, and/or
- Wire harness assembly
- Ability to translate quality improvements to cost savings
- Certified quality auditor
Compensation
- Annualized at $140,000 - $150,000, plus bonus.
Benefits
- Kestra offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.
- Pay equity is an important part of Kestra's Culture.
- Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity.
- Maintains 100% compliance to Kestra Medical Quality Management System
- Depending on experience.Kestra Medical Technologies is an
Company info
- improvement
Equal opportunity
- equal opportunity employer.
Visa & Work Authorization
- We are unable to sponsor or take over sponsorship of employment visas at this time.
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