Quality Engineer - Supplier Assurance

ZEISS Group•Ontario, CA

About The Position

The Quality Engineer – Supplier Assurance plays a critical role in ensuring the quality, reliability, and compliance of products sourced from external suppliers. This position is responsible for developing, implementing, and maintaining robust supplier quality processes across the supply chain to mitigate risks, drive continuous improvement, and uphold the highest standards of product quality. In this role, you will work closely with suppliers and cross-functional internal teams to evaluate supplier capabilities, monitor quality performance, and lead corrective and preventive actions where needed. You will serve as a key partner in ensuring that supplier-related processes meet regulatory requirements and industry standards. This role has a direct impact on the safety, reliability, and performance of medical devices, supporting the delivery of high-quality products that meet both customer expectations and compliance requirements.

Requirements

Bachelor’s degree in Engineering (Mechanical, Electrical, Optical), Life Sciences, or a related field required
Minimum 5+ years of experience in Quality Assurance
Minimum 5+ years within medical device, pharmaceutical, or healthcare industries
Strong understanding of medical device manufacturing processes and products
Experience in supplier quality management
Hands-on experience with: NCR (Non-Conformance Reports) and CAPA processes
Process validations (IQ/OQ/PQ)
Strong knowledge of regulatory standards (e.g., ISO, FDA-GMP)
Proficiency in statistical analysis and quality methodologies
Strong technical writing and documentation skills
Ability to lift and/or move 5–15 pounds
Frequent standing and walking required
Repetitive hand use (grasping, fine manipulation)
Vision requirements include close, distance, peripheral, and depth perception
Full-time position (40+ hours per week)
Standard schedule: Monday–Friday, 8:00 AM – 5:00 PM
Occasional extended hours may be required based on business needs

Nice To Haves

Master’s degree preferred
Additional certification in Quality (e.g., CQE) is a plus

Responsibilities

Ensure all quality assurance activities comply with regulatory requirements, industry standards, and the company’s Quality Management System (QMS)
Maintain accurate, detailed, and up-to-date records in accordance with documentation and archiving requirements
Continuously assess and improve processes to ensure ongoing compliance with current regulations and standards
Ensure compliance of infrastructure within the Supplier Quality Assurance (SQA) function
Represent supplier quality processes during internal and external audits
Participate in and lead supplier audits
Develop, harmonize, and implement quality standards, procedures, inspection instructions, and measurement methods to improve process efficiency
Plan, execute, and evaluate validations and qualifications of processes and methods
Establish, qualify, and release new test equipment, including supporting maintenance planning
Lead risk management activities (e.g., pFMEA, control strategies) for new or updated processes
Provide training and guidance to internal teams to improve quality processes and practices
Collaborate cross-functionally to ensure alignment on requirements, expectations, and feedback
Own and manage the quality performance of assigned suppliers
Monitor supplier performance, identify gaps, and implement corrective and preventive actions (CAPA)
Maintain accurate supplier quality documentation and records
Identify and implement process improvements to enhance supplier quality and operational efficiency
Support continuous improvement initiatives across supplier quality processes
Train internal teams and suppliers on quality standards and expectations
Stay current on industry best practices and emerging technologies
Partner with Purchasing, Production, Quality, and R&D teams to improve the quality of purchased products
Support lifecycle management activities (e.g., change controls, CAPAs, LCM processes)
Participate in ongoing professional development to enhance technical and quality expertise