Quality Assurance Director, Northern Malaysia

Perak Permanent MYR300,000 - MYR500,000 per year
  • Be a part of a global medical devices firm
  • Working with a team of professionals leading the industry

About Our Client

Join our client, who is one of the leaders in the Medical Devices Industry.

Seeking a Quality Assurance Director based in Northern Malaysia. You will have comprehensive oversight of various functions, including Quality Assurance, Calibration, Supplier and Raw Material Management, Documentation, Microbiology, Customer Complaint Handling, CAPA, and audits.

Job Description

Leadership:

  • Articulate a vision, sense of purpose, strategy, and goals and objectives that ensure the team is focused, aligned, engaged, and empowered to achieve QA and overall business goals.
  • Establish the necessary governance models and management practices to ensure the team meets its goals and objectives.
  • Engage with stakeholders in a professional and constructive manner, ensuring that the Quality agenda is comprehended and valued by the broader Company team.
  • Drive talent development through sponsorship, coaching, mentoring, developmental assignments, and other formal and informal actions and systems.
  • Ensure the existence of a robust QA succession pipeline of talent for critical roles.
  • Lead a diverse group of employees, fostering an inclusive and empowered team that consistently evolves and adjusts to current and emerging business needs.

Quality Management:

  • Responsible for ensuring compliant quality systems that meet the business needs at APAC manufacturing facilities. Quality system documentation should adhere to the requirements of 21 CFR Part 820, ISO 13485, the European Medical Device Directives/Medical Device Regulation, the Japanese Pharmaceutical Affairs Law, and other international quality system regulations and standards as necessary.
  • Responsible for managing and overseeing all product QA activities at the site.
  • Set the strategic direction for QA in collaboration with the manufacturing sites and business partners.
  • Ensure that the appropriate budgets, resources, systems, and processes are in place with the aim of placing the patient at the center of everything we do, while also incorporating broader business goals.
  • Provide expert opinions, advice, and recommendations to the APAC QA Director.
  • Serve as a member of the Regional QARA Site team and the Leadership team.
  • Ensure that every employee within the site is focused on delivering the highest product and service quality standards to all our customers and their patients consistently, with the necessary systems in place to do so.
  • Adhere to and ensures compliance with Company's Code of Conduct, all Company policies, rules, procedures, and housekeeping standards.
  • Place integrity as a key behaviour and takes accountability for quality decisions.
  • Encourage innovative ideas from team members to enhance the robustness of the Quality process.

The Successful Applicant

  • Bachelor of Science Degree in Engineering, Medical, or a Science discipline is a minimum requirement. An advanced degree is preferred.
  • Minimum of 8 years' leadership experience in the medical device industry, with at least 12 to 15 years' experience in regulatory and/or quality functions commensurate with the responsibilities outlined above.
  • Extensive experience in compliance with the US Quality System Regulation (21 CFR Part 820), Medical Device Directive/Medical Device Regulation, and the ISO 13485 quality system requirements.
  • Comprehensive knowledge of quality techniques and practices as they relate to the medical device industry.
  • Track record of developing organisational capability through people, systems, and process development.
  • Experience working in a dynamic, multinational matrix environment.
  • Strong business acumen and the ability to influence the direction of the company.
  • Audit experience for various regulatory bodies is desirable but not essential.
  • High proficiency in English

What's on Offer

  • An exceptional opportunity to join an MNC and become part of a leadership role.
  • Executive compensation package included.



Contact
Carmen K Lee
Quote job ref
JN-082023-6139728
Phone number
6012 375 2458

Job summary

Function
Engineering & Manufacturing
Specialisation
Quality, Technical
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
Perak
Contract Type
Permanent
Consultant name
Carmen K Lee
Consultant contact
6012 375 2458
Job Reference
JN-082023-6139728

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.