Director Quality Assurance

2 weeks ago

Penang, Malaysia Dexcom Full time

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company’s inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

**Role Summary**:
As a member of the site leadership team this is an opportunity for an experienced impactful Quality Assurance Leader to significantly contribute to the scale up and ongoing operations of Dexcom facility in Penang Malaysia.

Key will be ramping and sustaining a Quality structure that supports all elements required for successful leadership and compliance of the facility and operation. Key areas of focus will be People, Manufacturing, Logistics and Distribution, Supply Base, and Sterilization workstreams.

**Essential Duties and Responsibilities**:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required:

- Site Management Representative for the Site. Individual is primary interface during Notified body, FDA, or other regulatory body inspections.
- Ramp up of the Quality function in the manufacturing facility, providing leadership to this Quality team so as to ensure quality compliance across all functions;
- Hiring personnel for Operations Quality and compliance support
- Maintain robust compliance program ensuring compliance to local, national and international regulatory standards, company policies and procedures, and Corporate requirements
- Guiding all steps of the manufacturing realization program to ensure fully compliant to all expected guidelines and regulations pertaining to quality
- Engagement in supplier selection, ensuring development and qualification
- Ensuring successful facility validation including cleanroom(s), environmental controls, infrastructure systems, and equipment.
- Support on an ongoing basis;
- Strategic planning in the short and long-term from a technical (Quality and Regulatory) perspective
- Creation and achievement of site goals as aligned to the overall quality and regulatory strategy.
- Directs the Operations Quality Assurance Teams. Responsibilities include Quality Engineering, Document Control, CAPA, Non-Conforming Product, Microbiology, Calibration, Receiving Inspection and Lot Release. Defines priorities and delegates responsibilities.
- Establishes, reviews, and approves site and corporate procedures, as appropriate.
- Directs or conduct personnel training on domestic and international requirements and industry best practices. Ensures employee conformance to established requirements and proper training of staff
- Actively work in collaboration with other internal departments and external partners to ensure projects are delivered on time in compliance and in line with regulatory authority requirements.
- Continually seek opportunities for improvement while supporting a culture of knowledge sharing and learning
- Focus on people;
- recruitment, retention and motivation of the quality and regulatory team.
- Provide leadership and development to all direct reports assuring active participation in performance management, succession planning and talent development activities.
- Support new product introduction and technology transfer and support registrations.
- Reporting on the effectiveness of the Quality Management System through regular reporting.
- Lead the organization through any required regulatory, and external audits.
- Management of budgets for the quality department and input to overall annual budget process.

**Required Qualifications**:

- Minimum of 15+ years of quality compliance experience (8 of which should be managing both direct reports and larger indirect organizations).

**Preferred Qualifications**:

- Sterility Assurance experience an advantage
- Experience in hosting regulatory inspections and/or conducting supplier audits
- Experience of greenfield start up/scale up an advantage
- Prior experience in high volume, clean room operations and monitoring

**Experience and Education Requirements**:

- Bachelor’s Degree in a relevant discipline required; Advanced Degree such as MBA, preferred
- Medical device industry experience in operations quality
- Experience in hosting regulatory inspections

**Travel Required**:

- 20%

  • Associate, Audit and Assurance

    2 months ago

    Penang, Malaysia OA Assurance PAC Full time

    Job Highlights:Working with a recognised Accredited Training Organization Working Days: Monday to Friday Working Hours: 9am to 6pm A supportive and collaborative work environment.Job description:Carry out audit procedures in accordance with audit plan and SSAs Prepare draft financial statements in accordance with Singapore Financial Reporting Standards...

  • Associate, Audit and Assurance

    3 weeks ago

    Penang, Malaysia OA Assurance PAC Full time

    Job Highlights:Working with a recognised Accredited Training Organization Working Days: Monday to Friday Working Hours: 9am to 6pm A supportive and collaborative work environment.Job description:Carry out audit procedures in accordance with audit plan and SSAs Prepare draft financial statements in accordance with Singapore Financial Reporting Standards...

  • Senior Associate, Audit and Assurance

    3 weeks ago

    Penang, Malaysia OA Assurance PAC Full time

    Responsibilities:Carry out audit procedures in accordance with audit plan and SSAs Prepare draft financial statements in accordance with Singapore Financial Reporting Standards Managing audit engagements which include initial engagement planning, analysis of controls and processes, preparation andreview of audit documentation and management letters and...

  • Senior Associate, Audit and Assurance

    2 months ago

    Penang, Malaysia OA Assurance PAC Full time

    Responsibilities:Carry out audit procedures in accordance with audit plan and SSAs Prepare draft financial statements in accordance with Singapore Financial Reporting Standards Managing audit engagements which include initial engagement planning, analysis of controls and processes, preparation andreview of audit documentation and management letters and...

  • Quality assurance manager

    1 month ago

    Penang, Malaysia Net2source Llp Full time

    Position:Senior Quality Assurance ManagerWork Location: Kuala Lumpur, MalaysiaJob Type: PermanentLanguage: Mandarin, Cantonese (proficiency in reading, writing, and speaking)Experience: Minimum 6 years in Customer Service, Content Moderation, Quality Management, Team Leadership in BPOLead and oversee a QA team: implement and supervise initiatives related to...

  • Quality assurance manager

    3 weeks ago

    Penang, Malaysia Net2source Llp Full time

    Position:Senior Quality Assurance ManagerWork Location: Kuala Lumpur, MalaysiaJob Type: PermanentLanguage: Mandarin, Cantonese (proficiency in reading, writing, and speaking)Experience: Minimum 6 years in Customer Service, Content Moderation, Quality Management, Team Leadership in BPOLead and oversee a QA team: implement and supervise initiatives related to...

  • Intern - Quality Assurance

    3 weeks ago

    Penang, Malaysia Dexcom Full time

    **Scope**: - Work closely with Receiving Inspection, Project Quality Engineers, and Supplier Quality Engineers to implement inspection methods, sampling plans, and related procedures. - Provide the primary input to the design, development, and implementation of fixtures for measuring component parts in Receiving Inspection. - Conduct measurement capability...

  • Quality Manager

    3 weeks ago

    Penang, Malaysia Flex Full time

    Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the...

  • Assistant Director

    3 days ago

    Penang, Malaysia JAC Malaysia Full time

    Location: - Penang- Specialisation: - Entertainment- Salary: - MYR 60,000 - 65,000 (Annual)- Reference: - PR/156845- Contact details: - Charmaine Loo- Job published: - March 05, 2024 14:36**JOB DESCRIPTIONS** - Assist the director with administrative matters, arranging meetings, making schedules, managing files and documents. - Assist the director in the...

  • Quality Assurance Analyst Native Japanese/ Mandarin

    2 weeks ago

    Penang Island, Malaysia Gratitude Inc. Full time

    **Role**:Quality Manager **Timings**:Flexible (Permanent) **Industry**:BPO **Work Mode**:Work from office **Functional Area**:ITES / BPO / Customer Service **Process**:Voice Key Skills: Quality assurance Quality Assurance/QA - Details: Basic salary: RM9,000 - RM14,000 Location: LV, Georgetown Penang Shift: 24/7 Rotational DOJ: March 2024 HC...

  • Quality Assurance Inspector

    2 months ago

    Penang, Malaysia AKT Components Full time

    To monitor the quality of product. - To inspect the quality of product as per the requirement specification. - To perform Incoming Inspection, In-Process Inspection and Final Outgoing Quality Inspection of products as per specification. - To make recommendation on approval and disapproval of inspection results. - To carry out product inspection and handle...

  • Quality Manager

    3 weeks ago

    Penang, Malaysia Flex LTD Full time

    Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the...

  • Quality assurance analyst

    4 weeks ago

    Penang, Malaysia Teleperformance Full time

    Overview Job Summary If you are possess with attention to details and has the ability to deep dive into collected data from Quality monitoring and reporting feedback, We have something for youQualifications Main Requirements: Bachelor's degree or equivalent diploma in any discipline Candidate must be able to work on rotational shift. Minimum 1 years'...

  • Quality assurance analyst

    1 week ago

    Penang, Malaysia Teleperformance Full time

    Overview Job Summary If you are possess with attention to details and has the ability to deep dive into collected data from Quality monitoring and reporting feedback, We have something for youQualifications Main Requirements: Bachelor's degree or equivalent diploma in any discipline Candidate must be able to work on rotational shift. Minimum 1 years'...

  • Quality assurance analyst

    3 weeks ago

    Penang, Malaysia Teleperformance Full time

    Overview Job Summary If you are possess with attention to details and has the ability to deep dive into collected data from Quality monitoring and reporting feedback, We have something for youQualifications Main Requirements: Bachelor's degree or equivalent diploma in any discipline Candidate must be able to work on rotational shift. Minimum 1 years'...

  • Quality Assurance Analyst Native Japanese/ Mandarin

    1 week ago

    Penang Island, Malaysia Gratitude Inc. Full time

    Role:Quality ManagerTimings:Flexible (Permanent)Industry:BPOWork Mode:Work from officeFunctional Area:ITES / BPO / Customer ServiceProcess:VoiceKey Skills: Quality assurance Quality Assurance/QA Details:Basic salary: RM9,000 - RM14,000Location: LV, Georgetown PenangShift: 24/7 RotationalDOJ:March 2024HC Required : 4HC (Japanese)Requirement:Native...

  • Quality Eng

    4 weeks ago

    Penang, Malaysia Boston Scientific Corporation Full time

    **Work mode**:Onsite**Onsite Location(s)**:Penang, MY**Purpose Statement** - Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental,...

  • Director of Rooms

    2 months ago

    Penang, Malaysia Shangri-La Hotels Full time

    Shangri-La Rasa Sayang, Penang Shangri-La Hotels and Resorts began in 1971 with our first deluxe hotel in Singapore. Today, the group comprises over 102 deluxe hotels and resorts in key cities in Asia Pacific, North America, Europe and the Middle East. Based in Hong Kong, we are expanding globally with developments under way throughout Asia, the Middle East...

  • Quality Analyst 1

    2 months ago

    Penang, Malaysia Dexcom Full time

    About Dexcom Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and...

  • Quality Analyst 1

    3 days ago

    Penang, Malaysia Dexcom Full time

    About Dexcom Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and...