Head of Quality Assurance
6 days ago
We are seeking a highly skilled and experienced professional to join our team as a Head of Vigilance at Sinclair, a global medical aesthetics organization. As a key member of our Quality Assurance team, you will play a critical role in ensuring the highest standards of quality and compliance in our medical device products.
Key Responsibilities- Lead the Vigilance Team in complaint handling, medical device reporting, and supporting manufacturers to investigate complaints.
- Develop and implement initiatives to improve quality and efficiency within the Complaint Management Team.
- Collaborate with Injectables and Active Device manufacturer's quality teams to deliver results to defined KPIs and strategic initiatives.
- Ensure work instructions and procedures are in compliance with all applicable FDA regulations, including 21 CFR Parts 820 and 803, and Regulation (EU) 2017/745.
- Maintain regulatory, process, and product knowledge to provide internal and external audit support.
- Minimum 5 years' experience in Quality Assurance or Complaint Management within a Medical Device or Aesthetics organization.
- Working knowledge of the Medical Device Regulation and 21CFR Part 803, 820.
- Knowledge of other regulatory requirements.
- 25 days annual leave (plus bank holidays).
- Bonus based on performance.
- Free parking.
- Opportunities for development and progression.
- Company pension scheme.
- Private medical insurance.
- Healthcare Cash plan.
- Health Screening.
- Employee Assistance Programme.
- Store discounts.
- Tech and Cycle Scheme.
- Discounted dining card.
- Cycle to work scheme.
- Green car scheme.
- Holiday buy and sell.
- Life Assurance scheme.
Sinclair is a global medical aesthetics organization that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.
We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability, and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development, and a varied workload.
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