08 - Specialist, Operations Quality

General Overview

Functional Area:  Quality (QUA)
Career Stream:  Operations Quality (OPQ)
Role:  Specialist (SPE)
Job Title:  Specialist, Operations Quality
Job Code:  SPE-QUA-OPQ
Job Level:  Band 08
Direct/Indirect Indicator:  Indirect

Summary

We are hiring a Quality Specialist (Medical / Health Tech) to manage customer quality specifications, Quality Management System (QMS) requirements, and process validations, reporting directly to the Quality Manager.

The Quality Specialist leads quality planning for the Health Tech (HTC) medical segment, drives continuous process improvements, reviews validation protocols, and oversees quality data reporting to ensure high customer satisfaction. This role may also lead working groups or project teams of technical and support staff.

Detailed Description

Performs tasks such as, but not limited to, the following:

NPI & Quality Planning: Lead quality onboarding for new HTC customers and New Product Introduction (NPI) activities, including First Article Inspections (FPA/First Item Reports), PPAP documentation, and Control Plans.

Documentation & Change Control: Create, review, and update work instructions, SOPs, and process documentation. Manage Engineering Change Notifications (ECN) and Process Change Notifications (PCN) in line with ISO and FDA regulations.

Audits & Compliance: Act as lead auditor for internal, process, product, system, supplier, 5S, safety, and regulatory compliance audits.

Data Analysis & Reporting: Collect and analyze quality KPIs (scrap rates, process yields), prepare Quarterly Business Review (QBR) reports, and present data to internal and external stakeholders.

Issue Resolution & Risk Management: Lead root cause analysis, CAR/SCAR, and corrective/preventive actions for customer complaints. Coordinate the Material Review Board (MRB) and Return Material Authorization (RMA) processes, while managing PFMEA and ESD/MSD compliance.

Team Leadership & Mentorship: Establish annual objectives, assign tasks, evaluate performance, and provide technical training to quality technicians and engineers.

Knowledge/Skills/Competencies

• Solid expertise in ISO 9001, ISO 13485, ISO 19011, ISO 14001, ISO 50001, ISO 14971, and FDA CFR rules (such as CFR 820/821).

• Proficient in MS Office, Statistical Process Control (SPC), PFMEA, 8D methodology, Control Plans, and process validation. Lean Six Sigma and supply chain/inventory management knowledge are strong advantages.

• Advanced English language skills, strong analytical capabilities, effective communication skills.

Physical Demands

• Duties of this position are performed in a normal office environment.
• Duties may require repetitive manual movements (e.g., keyboarding), carrying, pushing or pulling light objects, (under 5 kg.), carrying, pushing or pulling heavy objects (over 5 kg.), crouching, climbing
• Sustained visual concentration on small areas, such as monitors, screens, precise eye/hand coordination, sustained visual concentration on numbers, legal documents

Typical Experience

• 4 to 6 years in a similar role or industry.

Typical Education

• Bachelor's degree in related field, or consideration of an equivalent combination of education and experiency.
• Educational requirements may vary by geography.

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.