Katalyst CRO · 9 hours ago
Supplier Quality Engineer
Latham, NY
Contract
Onsite
Mid, Senior Level
4+ years expKatalyst CRO is seeking a Supplier Quality Engineer who will be responsible for implementing Quality Engineering and Supplier Quality processes. The role focuses on ensuring supplier compliance with regulatory requirements and driving supplier quality improvements across the supply base.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Implement Quality Engineering, Purchasing Controls, and Supplier Quality processes for manufacturing materials, components, software, sub-assemblies, finished devices, products, and services
Evaluate suppliers' critical quality processes and ensure compliance with regulatory requirements and procedures
Drive supplier improvement through Supplier Quality Improvement Plans (SQIPs)
Lead the Supplier Change Notice process with support from Engineering, Quality Engineering, and Quality Assurance
Qualify suppliers, assess supplier metrics, and audit critical supplier quality processes
Ensure validations are completed where specified and control plans exist to sustain quality and compliance of supplied raw materials and components
Independently produce and complete Supplier Quality Engineering activities and documentation
Complete qualification of materials and components (including spare parts)
Develop and improve supplier processes for Critical-to-Quality (CtQ) characteristics, including supplier process control plans
Ensure supplied parts meet specifications and CtQ control limits and tolerances
Qualify and sustain supplier sub-processes, including performing process validations for critical supplier processes impacting part quality
Ensure components, products, spare parts, and services are released according to agreed specifications, quality requirements, APQP/PPAP, and SQ audit results
Execute SCAR management and ensure effective and timely closure involving Regulatory, Manufacturing Engineering, R&D, Clinical, and other stakeholders
Lead process improvement methodologies and organizational change management initiatives
Develop suppliers and implement lean methodologies at supplier sites
Develop and support closure of regulatory compliance gaps at suppliers, including supplier quality system and process development activities
Manage additions, deletions, and changes to supplier status on the Approved Supplier List, including supplier master file records
Ensure raw materials, components, and products are released from suppliers according to agreed requirements
Perform third-party product compatibility risk assessments in partnership with R&D and Market Procurement (Markets SQE)
Drive quality and compliance development and improvement at suppliers as needed
Support travel to supplier sites within the assigned region
Qualification
Required
Bachelor's degree in Engineering or Science discipline, or equivalent experience
Minimum of 4 to 8 years of experience establishing and maintaining regulated supplier management systems
Experience engineering quality and ensuring compliance for raw materials, components, and finished products
Certification with a recognized accreditation body (RAB-QSA/IRCA) or ASQ certification such as Certified Quality Engineer (CQE) or Certified Quality is an advantage
Certified Quality Auditor (CQA), Certified Biomedical Auditor, or completion of a recognized Lead Auditor course is an added advantage
Excellent written and verbal communication skills in English
Demonstrated experience in collaborative working environments, conflict resolution, and stakeholder influencing
Ability to drive progress, take initiative, and achieve results
Experience with technical drawings and part specifications
Experience in manufacturing processes including welding, soldering, crimping, injection molding, plating, casting, and thermal forming
Preferred
Experience with APQP (IQ, OQ, PQ)
Experience in technical writing of protocols and reports
Experience with ISO 9001 and ISO 13485 is a plus
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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