Solentim are Recruiting | Quality Engineer, Wimborne, UK, Full-Time
We are a global company with staff based in Europe, Asia and the USA. Our products are used by pharmaceutical and biotech companies all over the world. We are a fast growing, innovative organisation with a strong team of highly-skilled, talented individuals working together in a friendly, creative and fast-paced, environment – all striving to make a difference to the lives of patients.
The primary responsibilities for the Quality Engineer position will be to provide leadership to the organization in the areas of Quality, Supply Chain Management and Operations support so that Quality issues are managed as effectively as possible to minimize the impact on the business.
Key Duties & Responsibilities:
- Work effectively with colleagues in cross-functional or departmental team projects.
- Work with Receiving Inspection personnel within Advanced Instruments to manage Customer/Supplier issues.
- Work with the Production Engineer to resolve supplier and process issues in a timely manner.
- Monitor product quality levels via review of non-conforming reports, CAPAs and Customer Complaint records and drive learnings/opportunities for improvement back into the Supply Chain.
- Lead the identification and elimination of risks that could impact the achievement of first-time quality.
- Perform Supplier performance reviews and maintain Supplier Scorecards.
- Plan and execute product and process related Supplier audits, drive preventative actions at the supplier’s facility and minimize Supplier escapes.
- Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks through Component Qualification and Process Validation.
- Lead Quality Improvement projects as required to support business deliverables.
- Participate in the internal audit program, and complete audits as per the internal audit program to closure.
- Assist in the ongoing developments of the QMS in line with company Strategy.
Experience & Background:
- Experience in Medical Device or regulated industry experience.
- Working knowledge of Quality System Regulation ISO9001 and ISO 13485.
- Experienced auditing to ISO9001 and ISO13485.
- Demonstrated ability to work independently and effectively manage multiple priorities.
- Strong organizational, written and verbal communication skills.
- Trained in Problem Solving – Root cause Analysis, 8-D process; Internal Auditing and Lean Manufacturing
Closing date: 4th February 2022
To apply: Please send your CV, together with a covering letter outlining why you’re interested in the role and why you’d be perfect for it, to: [email protected]
For further information or an informal discussion: please contact the recruiting manager, Simon Jennings, Quality Manager, [email protected]