Quality Assurance Manager - Cirencester, UK
Corin, United Kingdom
Job Description
Corin is seeking a Quality Assurance Manager to ensure that all quality management system (QMS) requirements are met within the Corin Group and they are integrated in the business systems employed by Corin Ltd. Implement, establish and maintain a Quality System in accordance with ISO13485/MDR/ 21CFR820 and other regulations as required.
Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. Corin offers a unique combination of clinically proven hip amp; knee solutions and world leading technologies, our OMNIBotics amp; OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.
Key results areas:
- To gain and maintain all international QS based approvals as demanded by business needs.
- Effective reporting of KPI and improvement planning activity
- Demonstrated ability to influence and interact effectively across a global organization.
- Compliance with pre-agreed timelines.
The key responsibilities of the Quality Assurance Manager are to:
- Manage quality representatives with respect to dealings with regulators and compliance with reporting requirements for Corin UK and France.
- Manage and resource all aspects of the quality assurance team
- Monitor compliance and ensure adherence to standards of quality control resources within manufacturing quality / end of line inspection and goods inwards support functions as well as deployed Quality Engineers within the NPI Engineering team.
- Ensure compliance with the requirements of the European Medical Devices Directives, ISO 9001, ISO 13485, MDR, FDA 21CFR Part 820, Canadian medical device regulation, Brazilian medical device regulation, Japanese medical devices regulation ISO 17025 and other regulatory requirements as identified.
- Lead Management review of Quality performance.
- Set and complete internal and supplier audit schedules.
- Identify and provide the training needs of all personnel with regards to GMP and the regulatory environment and ongoing compliance enforcement.
- Manage change control and document control as well as the development of the Electronic Quality Management System
- Monitor, trend and manage / report the effectiveness of the Corin Ltd QMS and its KPI’s - the key outputs being internal audit system, complaints management and CAPA system.
- Manage the system of supplier evaluation and approve or disqualify suppliers accordingly as well as setting quality standards and development requirements.
- Manage and administer the Corin Ltd concession/waiver and Risk Management processes
- Administer the Corin Ltd Standards and Specification holding.
- Be a key stakeholder and champion of Corin’s Quality Assurance strategies and key improvement programs.
- Track, analyse and resolve customer and routine production quality needs / problems.
- Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS amp; Good Manufacturing Practice (GMP) FDA21 CFR Part 820
- Ensure that process amp; timeline requirements for Corrective amp; Preventive Actions (CAPA) are met in accordance with Corin’s Standard Operating Procedures (SOP’s) and in support of Corin’s Global Objectives for CAPA.
Requirements
The ideal Quality Assurance Manager will have / be:
- A BS degree in Engineering and/or science discipline; MS degree in Engineering and/or science discipline preferred.
- Strong Quality Management background with an in-depth understanding of the European Medical Devices directives and the FDA QSR with respect to their application to a manufacturing environment.
- Strong influencing and persuading skills to support the maintenance of quality systems and regulatory compliance through others. Proven Project Management and problem-solving skills.
- Experience of handling Quality Management Systems and implementing process changes
Benefits
You will receive a competitive salary and annual bonus as well as:
- 25 days holiday plus bank holidays.
- Excellent pension up to 9.7% provided by Corin when you contribute 4%
- Life assurance (6x basic salary).
- Private medical insurance with BUPA for you and your family.
- Subsidised canteen and gym membership.
- Free car parking - close to Swindon, A419, Cheltenham, Gloucester and Stroud.
- Friendly and collaborative working environment
Corin is an equal opportunity employer. Qualified applicants are considered without regard to age, gender, race, creed, colour, national origin, ancestry