Job Description
Biocomposites, Ltd. is a global medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue. Based in Keele in Staffordshire, UK, it has global operations across Europe, USA, Canada, Argentina, China and India, and helps more than 1 million patients worldwide every year!
We are distinct in that our team of specialists is singularly focused on the development of innovative calcium compounds and all research, manufacture and distribution takes place at our headquarters in Keele, England. In 2022, Her Majesty the Queen honoured us with two Queen’s Awards for Enterprise in Innovation and International Trade in recognition of the impact of STIMULAN in infection cases and our outstanding continuous growth in overseas sales of more than 200% over six years. Biocomposites products are now used in over 120,000 procedures every year and sold in more than 40 countries around the world.
BACKGROUND:
Biocomposites continues to experience dramatic growth, realising our mission to increase the number of patients we can help, by extending our market coverage in new specialities and new geographies.
As the Quality Supplier Specialist you will conduct the management of the supplier portfolio including supplier evaluation, approval, disapproval, audits, corrective action management and performance monitoring.
RESPONSIBILITIES:
1. Maintain, develop, improve and update the Quality Supplier procedures as per the applicable standards
2. Drive continuous improvement initiatives to achieve supplier quality
3. Develop supplier base with a focus on supplier quality
4. Support all departments with setting up of new suppliers
5. Conducting evaluation of suppliers
6. Monitoring and updating supplier information and certification as part of the supplier schedule
7. Maintain the ERP and eQMS system up to date with supplier information
8. Schedule, support and conduct supplier audits to verify compliance and customer specific requirements, as applicable
9. Investigate and work alongside suppliers to determine root cause for supplier quality issues and confirm implementation of corrective actions
10. Support business non-conformances relating to suppliers raised through internal and external audits
11. Collate data for trending and analysis to support quality data reports, metrics and continuous improvement
12. Collaborate with R&D/Product Development teams playing an active role in new supplier selection, qualification, development and approval
13. The role requires travelling and often nights away within the UK, with on the odd occasion overseas.
REQUIRED EXPERIENCE:
1. Level 5 degree or equivalent (or 3+ years QMS / QA / auditing role)
2. Minimum of two years’ experience in a Quality, Supplier Quality or Engineering role in a manufacturing environment within a regulated industry
3. Working knowledge of QMS principles e.g. policies and procedures, regulatory requirements, supplier management, CAPA
4. Lead Auditor ISO13485
5. Worked within healthcare (medical devices or pharmaceutical) manufacturing
6. 2 + years auditing experience
7. Working knowledge of QMS / GMP Procedures e.g. ISO 13485, ISO 14971, MDR (EU), QSR (US)
8. Ability to work in a diverse, dynamic and fast-paced environment
9. Excellent team player, with strong interpersonal and communication skills
10. Excellent verbal, non-verbal and written communication skills.
11. Accepts responsibility, excellent organization skills and attention to detail
12. Full, clean driving licence
LOCATION:
Based at Keele facility with occasional projects at Trentham facility. Working hours will be of a flexible manner with core hours Mon-Fri 08.00 - 16.00 or 09:00 - 17:00, but flexible to be able to operate between 07.45 - 17.15 whilst still working 35 hpw. Hybrid working.
What do we offer?
Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.
We grow talent. At Biocomposites we create opportunities to thrive and grow.
One Biocomposites - team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.
Who do we look for?
People Who Are Passionate About What We Do. People who are open minded to evolving the way we work. People who can work together to transform outcomes and change lives.
If you are interested please forward your CV and cover letter stating the position you wish to apply for to careers@biocomposites.com
Benefits:
1. Company events
2. Company pension
3. Employee discount
4. Free or subsidised travel
5. Free parking on-site parking
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