Quality Assurance Lead - Woundcare (Medical Devices)
- Recruiter
- Crawford Healthcare
- Location
- Tarvin Sands, Chester
- Salary
- £35,000 per annum plus bonus scheme
- Posted
- 13 Nov 2015
- Closes
- 08 Dec 2015
- Contract Type
- Permanent
- Hours
- Full Time
Main Purpose:
Under the direction of the QA & Regulatory Manager, maintain, support and improve the Quality Management System at Himedica Ltd and Crawford Healthcare's contract manufactures. To interpret and advise on the GMP's associated with Medical Device manufacturing/testing. To ensure that the manufacture/testing of products comply with the relevant international quality and regulatory standards ISO13485,FDA
Responsibilities:
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Management of the batch release system including performing release of sterile and non-sterile product, updating the system according to compliance with standards and working practises at Crawford Healthcare Ltd and document handling and storage.
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Handling day-to-day quality issues as they arise.
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Ensure that all sterilisation is up to date and fully within validation.
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Coordination and maintainance of the document control process.
- Develop and maintain systems to the required BSI standards –ISO 13485
- Develop and maintain systems to measure performance against established standards.
- Monitor performance (in relevant areas) according to agreed standards and take necessary action to communicate/advise/assist according to performance levels.
- Monitor and inform/communicate/apply standards created/maintained by external bodies, and integrate within internal quality management systems.
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Ensure timely response and closure of supplier and customer complaints
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Assume responsibility for co-ordinating the internal NCR program.
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Carry out Internal and external audit programs.
Product Release and Batch Review Processes
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To support the batch documentation review process, including the release of sterile and non-sterile products, to make sure they reviewed in an efficient and timely manner.
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To make quality decisions on product and to advise on and assist with solutions.
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To review the monitoring and reporting of environmental monitoring, bioburden trends etc ensuring it is all carried out in line with SOPs and paperwork correctly completed and filed away.
Document Control
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Coordination of the documentation control process.
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The creation, maintenance, review and approval of key documents and procedures.
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Provide support to the Regulatory Affairs Officer in creating and maintaining Technical Files.
Quality Systems
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Provide support to the manufacturing department by ensuring all necessary quality processes are in place and they work smoothly and efficiently.
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On a day to day basis liaise with contract manufacturers and suppliers and handle any quality issues that they may have – perform audits of the contract manufacturers and suppliers
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To provide effective levels of communication, directly advise and influence those within the team
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Responsible for delivering effective Quality Assurance training programmes to members of staff where applicable.
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Support the delivery of site quality objectives and where applicable provide support for wider business objectives.
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Lead HiMedica Quality Meetings
Complaints
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Coordinate and monitor all customer complaints to aid in the timely progression and closure of complaints.
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Work with departments providing information for risk evaluation.
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Support investigations and actions associated with complaints.
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Liaise with customers to ensure customer satisfaction is achieved.
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Generate metrics and communicate at the Quality Meetings.
Control of Non-Conformances
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Manage through to compliance the NCR, Deviation and CAPA process in a timely manner
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Coordinate NCR, Deviation and CAPA documents and track status of corrective actions to ensure documents are complete and all corrective actions closed.
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Apply the first level of risk management by using analytical skills and experience to make decisions, develop solutions, or more complicated judgements within general operating guidelines.
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Generate metrics and communicate at the Quality Meetings.
Audits
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Lead and perform internal and external audits, including suppliers and contract manufacturers to ensure compliance to regulatory requirements (MDD 93/42/EEC) and appropriate ISO standards.
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Develop ongoing improvement plans to ensure ongoing compliance.
Key Skills and Competencies
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Minimum 3 years experience of woundcare manufacturing and cleanroom experience essential
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Good knowledge of applicable legislation, cGMP, regulatory requirements (MDD 93/42/EEC, MHRA, FDA etc) and appropriate ISO 13485.
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Good written and verbal skills and good interpersonal skills.
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Excellent attention to detail.
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Well organised and structured approach to key tasks.
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Ability to work independently with minimal direction.
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Self-motivated, thorough and flexible.
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Ability to perform audits – internally and externally
Job Specifics
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Position is based at Himedica 75% of the time, with 10% of time at Knutsford and 15% out at Contract Manufacturers and suppliers (visits and audits).
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Hours are 8 am to 4.00 pm Monday to Friday
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Salary £35,000 per annum plus bonus scheme
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33 days holiday a year (inclusive of Bank Holidays)
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3 month probationary period in role