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Key skills for this role
Apply FDA, ISO, MDR and other regulatory standards across the business.
Review manufacturing and quality activities; support major process and QMS changes.
Develop and maintain compliant procedures and documentation; deliver training.
Support Departmental metric analysis including on-time trending and reporting, ensuring Quality KPIs and targets are met.
Support/lead non-conformance (NCR) and Corrective & Preventive Action (CAPA) processes as directed. Conduct and/or support data capture and root cause investigations, review actions for comprehensiveness, determine stock disposition, and analyze the data for the reasons of Quality Improvement and reporting.
Promote and support adherence to Corin’s Standard Operating Procedures (SOPs) and Global Objectives for timeliness.
Support internal and external audits; present QA systems confidently.
Assist with product complaint investigations and quality improvement actions.
Participate in Management Review, change control, and compliance meetings.
Champion continuous improvement, stakeholder engagement, and strong QA behaviours.
Adhere to Quality Management System (QMS) requirements in line with Corin’s Good Manufacturing Practice (GMP) and Good Documentation Practice (GDocP) as per ISO13485 & FDA21 CFR Part 820.
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Experience in internal/external audits (e.g., FDA, Notified Body, supplier).
Worked in QA within medical devices, or healthcare.
Demonstrated experience of CAPA, NCRs, Root Cause Analysis, Change Control, Risk Management, and statistical tools.
Degree or HNC/HND in Engineering (mechanical or biomedical preferred).
Strong problem-solving, with critical thinking and communication skills.
Knowledge of Lean/Six Sigma and continuous improvement methods.
Influencing and leading - Develop a network of internal resources to facilitate completion of tasks. Ability to question and challenge is key.
Planning and organizing : Complete daily work to meet established schedule.
Driving decision making and making an impact : Exercise authority within pre ‐ established limits and approval
A competitive salary dependant on experience £42,000 - £49,000 and a discretionary annual bonus of 7.5%
25 days holiday plus bank holidays
Excellent pension – starts at 6%, going up to 9.7% after 18 months.
Life assurance – Six times your basic salary
Private medical insurance with BUPA for you and your family
Free annual eye tests and flu vaccinations
Employee referral program where you can earn from £1,000 for each successful hire you recommend
IND007
Private British medical-device manufacturer supplying orthopaedic implants and connected technologies to surgeons, hospitals, and patients.
Visit company websiteJobs and hiring trendsGBP 42000-49000 yearly / year
Full-time
Senior
Onsite
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