JOB SUMMARY:

This role ensures supplier quality at SMC Ltd. by supporting Quality Systems Management and leading strategic auditing, supplier/component development, qualification, and sourcing in collaboration with Procurement, Operations, and Quality. The position is accountable for Supplier Quality Engineering deliverables across new product development, manufacturing launch, and sustaining activities, while driving continuous improvements. Responsibilities include providing customer and supplier support through effective root cause resolution and proactive issue prevention, ensuring safe operations and overall team success. Performance is evaluated on execution, adherence to timelines, production support, quality outcomes, communication, continuous improvement, and strong cross-functional collaboration.

ESSENTIAL QUALIFICATIONS:

• Bachelor’s degree in Engineering or a related technical discipline.
• 2–4 years of experience in a Supplier Quality role within the medical device manufacturing industry, with strong knowledge of ISO 13485:2016 and 21 CFR Part 820 requirements.
• Hands-on experience with Gage R&R, CpK/PpK studies, and Design of Experiments (DoE).
• Proficiency in validation/qualification activities (IQ, OQ, PQ).
• Solid knowledge of risk management standards (ISO 14971) and application of risk assessment techniques such as FMEA.
• Familiarity with quality processes and tools including CAPA, PPAP, Root Cause Analysis, and structured problem-solving methodologies (e.g., 8D, 5 Whys).
• Experience planning and conducting supplier audits to ensure compliance with quality standards and regulatory requirements.
• Strong understanding of ISO 13485 quality systems and regulatory expectations under 21 CFR 820.
• Proficient in Minitab and the Microsoft Office Suite (Excel, Word, PowerPoint, Outlook).
• Excellent interpersonal, verbal, and written communication skills.
• Proven ability to prioritize tasks, manage time effectively, and meet deadlines.
• Detail-oriented, with a strong focus on accuracy, consistency, and quality in deliverables.
• Ability to read, write, and communicate effectively in English.

Desirable Qualifications:

• Experience with metrology equipment, measurement methods, and inspection techniques.
• Proficiency in CMM and MicroVu programming for precision measurement and validation.
• Project Management training or certification (e.g., PMP or equivalent).
• Six Sigma Green Belt certification or demonstrated application of Lean Six Sigma methodologies.
• Certified Lead Auditor or completion of recognized lead auditor training

ADA REQUIREMENTS:

The employee must be able to perform medium work, exerting up to 50 pounds of force occasionally and/or negligible force frequently to move objects. This role requires extended periods of sitting while using a computer and performing repetitive motions with the wrists, hands, and fingers. Close visual acuity is necessary to prepare and analyze data, review detailed information, view a computer screen, and perform extensive reading. The employee must also have the physical capacity to stoop, kneel, crouch, reach, stand, walk, push, pull, lift, grasp, feel, and communicate as required to perform essential job functions.
We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.
Annual Salary Range $86,000 - $103,000

• Plan, conduct, and document supplier audits to ensure compliance with quality standards and regulatory requirements.
• Manage supplier classification changes/updates and maintain accurate supplier records and information.
• Open, track, and follow up on Supplier Corrective and Preventive Actions (CAPAs) to drive timely resolution.
• Collaborate with Quality Engineers (QEs) on customer complaints related to supplier performance.
• Provide Supplier Scorecard inputs to support supplier performance monitoring and evaluation.
• Review, assess, and process supplier change requests in alignment with quality and regulatory requirements and in collaboration with applicable stakeholders.
• Support supplier selection, classification, and initial evaluations for new and existing suppliers.
• Manage Supplier PPAPs (Production Part Approval Process), including record creation in IQMS and communication with suppliers and customers.
• Collaboration in the development/improvement of receiving inspection instructions/techniques of purchased parts.
• Lead supplier Qualifications including (not limited to) activities such as, supplier Measurement System Analysis (MSA), tolerance and GD&T reviews, FMEA, control plans, FAI and DOE input for purchased components.
• Provide inputs and collaborate on Advanced Quality Plans (APQP) to ensure robust product launches and process controls.
• Contribute to the Validation Master Plan for purchased components and services, integrating supplier requirements into the overall validation strategy.
• Provide Supplier Quality technical support to Program Management Department.
• Collaborate in Engineering Change orders that impact purchase part or services
• Identifies and addresses opportunities for improvement to supplier related processes.
• Develops, maintains and updates Procedures, Work Instructions, and Forms
• Point of contact for suppliers, internal and external customers for supplier related issues
• Supports the ISO 13485 Business Management System through Internal Auditing.
• Assist with third party and FDA quality audits as needed.
• Perform other duties as assigned.