Job Information
Zimmer Biomet Regional PMS Quality Engineer in Bangalore, India
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
Job Summary
To monitor overall product complaint status across the region, run trending analysis with in country PMS team and push legal manufacturers/Complaint Handling Unit (CHU) to improve accordingly.
Collaborate Field Action related and CAPA related activities across the region and report to/follow up with corporate team as needed.
Monitor PMS related KPI in the region, including complaint origination, Adverse Event, MoH reporting, product hold, CAPA, etc.
Communicate with oversea manufacturer/CHU for Complaint /recall/AE handling.
Lead and coordinate regional project related to PMS improvement or efficiency improvement initiatives.
To establish & maintain related SOP, WI and/or system to be consistence with relevant regulations and company/process requirements.
To be responsible for participating in Global procedure discussions on behalf of APAC.
Improve quality management system and document control to ensure compliance with internal and external requirements.
To assist and support QARA Manager for all assignment on QA duties.
How You'll Create Impact
Principal Duties & Responsibities
To be responsible for regional PMS related processed development, implementation and maintenance. (30%)
To lead and coordinate regional PMS/QA related projects (20%)
To be responsible for complaint monitoring and improvement follow-up. (20%)
To be responsible for participating in Global procedure discussions on behalf of APAC. (10%)
To support QMS and Document Control maintenance in the region. (5%)
To assist and support QARA Manager for all assignment on QA duties. (5%)
This is not an exhaustive list of duties or funcitons and may not necessarily comprise all of the "essential functions".
What Makes You Stand Out
Expected Areas of Competence
Good communication skill, teamwork and proactive attitude.
Good problem-solving competence with project management experience.
Effectively managing one’s time and resources to ensure that work is completed efficiently.
Proactively participating as a member of a team to move the team toward the completion of goals.
Your Background
Education/Experience Requirements
Bachelor or master degree in Medical Science, biology, pharmacy, chemistry or other science related major, QA engineering background will be plus.
Above 5 years working experience in Post-market Surveillance of international Medical Device company
Professional Regulatory Knowledge on Regulatory history, guidelines, policies, practices, requirements in a regulated industry. Especially on recall, adverse event (AE) regulation.
Familiar with ISO 13485, QMS related regulation, Good Distribution Practice. ISO 13485:2016 Internal audit / Lead auditor certified will be plus.
Computer skills and be proficient with commonly used software.
Good at written and oral in English.
Physical Requirements
Travel Expectations
10%
EOE/M/F/Vet/Disability