Job Summary To drive continuous improvement of the 'cost of quality' objectives across our manufacturing site through systematic, preemptive analysis and improvement of process capabilities.
This position specifically owns investigations of a critical quality nature, utilizing root-cause analysis to identify and implement containment, corrective and preventive actions.
Key Duties/Responsibilities 1.
CAPA investigation; 2.
Quality Complaint investigation 3.
Change Management Quality lead; 4.
Internal Audits – to ISO13485, MDSAP, UK and EU requirements; 5.
Product & Process Risk Assessment; 6.
Product & Process validation / Approval; 7.
Product and Material specification generation and approval; 8.
Support Technical File required content creation; 9.
Lean Manufacturing – 5S, OEE, Conversion Loss, Right First Time; 10.
Own and maintain procedures, forms and records covering responsibilities of this position.
11.
CAPA management, Root Cause Analysis, Risk assessment & Action/s effectiveness reviews; 12.
Implement of kaizen projects based on complaints Target & Trend analysis, post-market surveillance or direct departmental feedback; 13.
FMEA, Control Plan, CAPA reviews to ensure Risk Priority Numbers remain current & valid.
Process controls implemented as a result need to loop back into the high-level Risk Management database; 14.
Completion of Product & Process validations, ensuring all documentation is retained and/or linked to the relevant Technical Files and that site Validation Master Plans are maintained; 15.
Management of Supplier Quality Assurance activities – e.g.
approvals, auditing; 16.
Support implementation of Lean Management principles in both Quality and Operations; 17.
Drive improvement to Cost of Quality measures including OEE, Conversion Loss, CAPA and Complaint reduction.
The above list of duties and responsibilities are not exhaustive and is subject to change.
The job holder may be required to undertake other duties within the overall scope and grading of the role as necessary to meet business demands.
Requirements Bachelor's Degree and minimum of 3 years of related experience (Medical Device preferred) required Familiarity with Quality Systems and regulatory agencies aligned to ISO 13485, EU MDR 2017/745, and FDA 21 CFR 820 preferred Internal Auditor experience, ideally certified Lead-Auditor qualification Knowledge, Skills & Abilities Excellent written and verbal communication skills, to support kaizen project implementations Creative problem-solving and troubleshooting skills, ability to drill down to root-cause using 6s tools High level of IT Microsoft Office skills, allowing creation of professional SOP / WINs Has a strong drive, passion and determination for achieving successful results Has a positive can-do attitude, enjoy working in a team and be keen to learn and develop Ability to work effectively with, and influence Operations personnel Holds themselves and others accountable to 'do the right thing'