Quality Manager

PerkinElmer; Gelang Patah; On-site; MYR 180,000 - 300,000; Full time

Job summary

PerkinElmer Quality Manager position in manufacturing requires establishing and maintaining the QMS to ISO 9001 and regulatory standards. You will lead QA/QC activities, drive CAPA and risk management, and ensure product safety and compliance across production.

The role also oversees audits, process validation, and transfers from R&D to production with a focus on continuous improvement. You will supervise quality engineers and technicians, coordinate with Regulatory and Global QMS teams, and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or Quality Management; 5+ years in medical device quality.
• 5+ years of quality management experience in regulated manufacturing environments.
• ASQ CQM/CQE or Lead Auditor certifications preferred.

Responsibilities

• Establish and maintain QMS in compliance with ISO 9001 and regulatory requirements.
• Lead CAPA, risk management, audits, and supplier quality programs.
• Oversee manufacturing QA/QC, in-process inspection, and product release.
• Drive process validation and equipment/software validation (IQ/OQ/PQ).
• Manage transfer of products from R&D/pilot to full-scale production.
• Mentor quality engineers and technicians; foster continuous improvement.

Skills

Leadership

Communication

Cross-functional collaboration

CAPA

Root cause analysis

Statistical analysis

Education

Bachelor's degree in Engineering, Life Sciences, Quality Management, or related field

Master's degree preferred

Tools

eQMS

Microsoft Office

Job description

The Quality Manager is responsible for establishing, implementing, and maintaining the Quality Management System (QMS) within a manufacturing environment, ensuring full compliance with ISO 9001and other applicable regulatory requirements. This role leads quality assurance and quality control activities across production, drives continuous improvement, manages CAPA and risk management processes, and ensures that all products meet the highest standards of safety, efficacy, and compliance.

Function as the site Quality Management Representative (QMR).

Responsibilities

Quality Management System (QMS)

• Maintain and continuously improve the QMS in accordance with ISO 9001and applicable regulations in close collaboration with the Gobal QMS team.
• Own and manage SOPs, work instructions, and quality records for the manufacturing environment.
• In collaboration with Global QMS and Supplier Management team, support internal, supplier, and third-party/notified body audits; manage CAPA arising from audit findings.
• Ensure readiness for inspections and lead site during audits.

Manufacturing Quality Assurance

• Oversee in-process and final inspection, incoming quality control, and product release activities.
• Manage nonconforming material processes, root cause analysis, and corrective/preventive actions (CAPA).
• Drive process validation (IQ/OQ/PQ) and equipment/software validation activities.
• Monitor quality metrics (yield, scrap, complaint rates,...) and report trends to leadership.
• Partner with Manufacturing and Engineering to resolve production quality issues and implement corrective actions.

Manufacturing Transfers & New Product Introduction

• Lead Quality's role in design-to-manufacturing transfer, ensuring products move from R&D/pilot into full-scale production without loss of safety, performance, or compliance.
• Own the transfer risk assessment, ensuring process FMEAs and design FMEAs are updated and reconciled to reflect the actual production process, equipment, and site.
• Review and approve transfer protocols and reports, including gap analyses between the sending and receiving sites (equipment, tooling, environment, operator skill, supply chain).
• Ensure process validation (IQ/OQ/PQ) and measurement system analysis (Gage R&R) are completed and approved prior to production release at the new site.
• Verify that critical-to-quality (CTQ) characteristics, control plans, and inspection/test methods are carried forward accurately from the originating process.
• Run structured first-article and pilot-run reviews with cross-functional teams (R&D, Manufacturing Engineering, Regulatory) prior to full-rate production sign-off.
• Track transfer-related nonconformances and CAPAs separately during ramp-up to identify systemic issues before they scale.

Failure Mode Analysis

• Facilitate Design FMEA (DFMEA) and Process FMEA (PFMEA) development, ensuring cross-functional participation from Engineering, Manufacturing, and Quality.
• Ensure severity, occurrence, and detection ratings are assigned using data (field history, complaint trends, process capability) rather than assumption.
• Drive identification of high-RPN (risk priority number) failure modes and ensure mitigation actions are assigned, resourced, and closed on schedule.
• Maintain FMEAs as living documents — updated following design changes, process changes, manufacturing transfers, CAPAs, and recurring complaints.
• Use failure mode data to define or refine control plans, in-process inspection points, and incoming inspection criteria.
• Apply root cause tools (Fishbone, 5-Why, Fault Tree Analysis) to validate that failure modes identified in the FMEA reflect real-world failure mechanisms.

Complaint Feedback & Post-Market Surveillance

• Own the feedback loop between post-market complaint data and manufacturing/design controls, ensuring field issues translate into concrete process or design improvements.
• Review incoming complaint trends on a regular cadence and correlate them against FMEA failure modes, updating risk ratings where field data reveals a higher real-world frequency or severity than originally assumed.
• Drive closed-loop corrective actions from complaints back into DFMEA/PFMEA updates, control plan revisions, work instruction updates, and operator training.
• Present complaint-driven quality trends, CAPA status, and risk file updates to management review

Risk Management & Compliance

• Lead overall risk management program including risk management file ownership and periodic risk/benefit review.
• Support complaint handling and field action processes as needed.

Team Leadership

• Supervise, mentor, and develop quality engineers, inspectors, and technicians.
• Establish training programs to ensure staff competency in quality systems.
• Foster a culture of quality, accountability, and continuous improvement across the organization.

Authorities

• Evaluate and approve hiring, promotions, and key personnel decisions for the department.
• Key signatory for external audit document
• Define policies, goals, and procedures for the department in alignment with company objectives.

Preferred Characteristics / Education & Experience

• Bachelor's degree in Engineering, Life Sciences, Quality Management, or a related field (Master's preferred).
• 5+ years of quality management experience in medical device or regulated manufacturing environments.
• 2+ years of experience directly supervising a quality team, preferred.

Certifications (Preferred)

• ASQ Certified Quality Manager (CQM) or Certified Quality Engineer (CQE).
• Certified Lead Auditor (ISO 9001).
• Six Sigma Green Belt / Black Belt.

Knowledge, Skills & Abilities

• In-depth knowledge of ISO 9001, other standards (ISO 14971, FDA 21 CFR Part 820, and EU MDR requirements.) are a plus.
• Proven experience with CAPA, root cause analysis (5-Why, Fishbone, FMEA), and process validation (IQ/OQ/PQ).
• Hands-on experience leading manufacturing/site transfers, including transfer risk assessments and first-article/pilot-run qualification.
• Demonstrated ability to build and maintain DFMEA/PFMEA and translate field complaint data into updated risk ratings and control plans.
• Strong statistical analysis skills (SPC, sampling plans, data trending).
• Excellent leadership, communication, and cross-functional collaboration skills.
• Experience hosting or supporting regulatory and notified body audits.
• Proficiency with quality systems software (eQMS) and Microsoft Office.