Job Description

Biocomposites, Ltd. is an international 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.

Job Summary

The US Quality Assurance Specialist will be responsible for facilitating all quality related daily activities of the US commercial and forward warehousing/logistics site: Accountable for all quality functions relating to Quality System: compliance, system maintenance documentation, the scope of which covers, complaints received, intercompany product quality, Nonconformances, Corrective and preventive actions, change management, internal and external audits and customer related issues.

Duties & Responsibilities

List key the duties & responsibilities for the role

• Promote a quality culture of ethical and business compliance through mentorship and training.
• Development, implementation, and maintenance of the company's Quality Management System in compliance with ISO13485, FDA CFR 21standards and any other regulatory requirements.
• Delivery of the day-to-day core quality management activities.
• Completing activities and maintaining records within the QMS related to Nonconformities and Corrective Actions, ensuring timely resolution and documentation.
• Ensuring corrective and preventive actions (e.g. scrap, rework, regrade, concessions, deviations) are documented, coordinated and completed within required timescales
• Ensure customer complaints and feedback are reported, documented, investigated, actions taken and completed within required timescales
• Lead in completing activities and maintaining records within the QMS related to internal and external audits, ensuring timely resolution and documentation.
• Lead in completing activities and maintaining records within the QMS related to change management, ensuring timely resolution and documentation.
• Lead in completing activities and maintaining records within the QMS related to supplier management, ensuring timely resolution and documentation.
• Perform product releases by reviewing and approving products or services, ensuring they meet established quality standards.
• Ensure that all process data, documentation, and reporting are maintained according to company standards.
• Collaborate with cross-functional teams to identify opportunities for process optimization and quality improvements.
• Ensure all staff are adequately trained in their relevant aspects of the quality management system.
• Occasional travel may be required to various sites, vendors or partner organsations.

Essential qualifications

• Level 5 degree
• Minimum 3 years quality management experience within Pharmaceutica/Medical Devices
• Knowledge of Quality Management Systems ISO13485 and FDA CFR 21
• Excellent communication skills
• People management skills
• Ability to take initiative within controlled working environment
• Ability to meet deadlines
• Attention to detail

Desirable qualifications

• Member of a chartered institute
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility
• 5+ years quality management experience within Pharmaceutica/Medical Devices
• Internal / Lead auditor certification
• Full, clean driving licence

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.