BioTalent is partnered exclusively with a 5 billion dollar medical device company, headquartered in the US. This is a company that cares about their people, products, consumers and the environment. They measure themselves on their successful engagement scores and pride themselves on having an "underdog mentality", which has allowed them to go from strength to strength. They are currently searching for an Product Quality Specialist

Responsibilities:

• To support and foster a Quality culture within the QA Ops team and the wider production environment
• Packaging component & finished product specification management
• Inspect incoming components and packaging components according to the relevant specifications, determining whether materials are fit for use
• Maintaining the line complaint system and ensuring that follow ups are met to close these out
• To provide Certificates of Analysis for stakeholders when required for stock shipped
• Work with internal stakeholders to ensure that all testing procedures are up to date and validated
• To ensure that Production adhere to GMP through training, collaboration and inspection
• Support the investigation of all complaints related to house produced cosmetics/medical devices
• Work cross-functionally with other relevant departments
• Maintain and report monthly RFT metrics and KPIs for in-house production, helping to drive improvements
• Supports the plant, QA Office and Laboratory 5S programmes

Requirements:

• Degree in a scientific area
• Experience within a similar role within a regulated industry is desirable
• Experience with ISO22716 & ISO13485 is desirable
• Able to build stakeholder relationships and be adaptable