Associate Specialist, Quality Assurance

6 months ago

Jakarta, Indonesia GE HEALTHCARE Full time

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
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**Role Responsibilities include (are not limited to)**:

- Hold the role of Technical Responsible Person (PJT - Penanggungjawab Teknis) of PT GE Operations and registered on IDAK License as PJT
- Perform roles and responsibilities of PJT based on the Indonesia MoH Regulation
- Implement quality management system as stipulated in CDAKB
- Develop basic and advanced training programs for CDAKB, and assure training of CDAKB implementation to all related personnel
- Lead the site internal audit program and support global/regions audit for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety
- Prepare site for external audits and implement corrective actions to address non-conformities.
- Support CAPA system through record ownership where appropriate.
- Coaching and mentoring functional teams on the development, maintenance and simplification of local procedures.
- Collect, summarize & evaluate performance metrics to identify QA weaknesses & drive improvements in procedures or oversight
- Support QMS and Bowler KPIs and business operating rigor with actionable data and analysis
- Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility
- Support continuous improvement activities regarding areas of responsibility
- Engage stakeholders and proactively communicate QA priorities & potential risks to business leads
- Analyze & communicate proposed, new or changing QA requirements & devise strategies for their implementation, ensuring business goals are met

**Required Qualifications**:

- Minimum Bachelor’s Degree Pharmacy or Biomedical Engineering
- Minimum 2 years OR minimum of 5 years progressive Quality Management Systems, and have experience as PJT in a Medical Device Company,
- Proven track record in performing external and internal audits (ISO13485/CDAKB)
- Ability to read, analyze, and interpret business plans, technical procedures and governmental regulations.
- Ability to prioritize, plan & evaluate deliverables to established strategic goals
- Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research

**Desired Qualifications**:

- Medical Device industry experience.
- Experience or certification on ISO13485 will be highly valued.
- Demonstrated experience interfacing with regulatory agencies (e.g. MoH, FDA) and standards bodies such as AAMI, IEC, ISO, UL.
- Knowledge of Quality Management Systems (QMS)
- Ability to work across cultures/countries/sites
- Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.

**Quality Specific Goals**:

- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility
- Effectively support implementation & management of current regulatory requirements within area of responsibility
- Ensure assigned regulatory submissions are accurate, complete and timely

**Desired Characteristics**
- Strong oral and written communication skills in English and local language. Demonstrated ability to analyze and resolve problems.
- Ability to document, plan, communicate and execute programs.
- Established project management skills.
- Strong attention to detail and thoroughness

**Inclusion and Diversity**

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

LI-ETEO

LI-ONSITE

LI-HYBRID

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