Quality Manager

Globus Medical; Borehamwood; On-site; GBP 55,000 - 65,000; Full time

Job summary

A leading medical device company in Borehamwood is seeking a Quality and Compliance Officer to lead quality assurance initiatives and ensure compliance with regulatory standards. Ideal candidates will have a strong understanding of quality systems and a minimum of 5 years of related experience. This role involves collaboration with internal teams and may require some travel.

Qualifications

• Minimum of 5 years of relevant experience or equivalent professional experience.
• Approximately 25% travel required.

Responsibilities

• Lead investigations into quality and compliance matters.
• Ensure compliance with national and EU regulatory frameworks.
• Perform audits and risk assessments.

Skills

Strong understanding of quality system requirements

Excellent communication skills

Proficient in MS Office applications

Education

Bachelor's degree or advanced degree

Job description

Supports the organization with initial compliance and ongoing preparation, testing and monitoring product conformance to established quality assurance processes and standards. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Perform audits and risk assessments as needed.

Essential Functions

• Lead investigations into quality and compliance matters, ensuring timely resolution and appropriate follow-up with internal and external stakeholders.
• Develop and review standardized reporting tools (queries, charts, analyses) to support Quality Assurance (QA) and Regulatory Affairs teams.
• Perform data analysis in support of customer correspondence, surgeon meetings, site visits, and regulatory agency requests.
• Execute product quality complaint investigations and prepare failure investigation reports.
• Ensure all quality system activities are implemented and maintained in accordance with applicable regulations and standards.
• Provide accurate and timely reports for internal and external customers.
• Perform additional duties as required to support the Quality and Regulatory functions.

Regulatory Responsibilities

• Act as NuVasive UK’s and Globus Medical UK’s Designated Individual (DI), fulfilling all statutory obligations.
• Act as Globus Medical Netherlands B.V.’s Responsible Person (RP), fulfilling all statutory obligations.
• Ensure compliance with national and EU regulatory frameworks, including HTA requirements, EU Directive 2004/23/EC, and EU Directive 2006/17/EC.
• Maintain up-to-date quality systems (QMS), procedures, training, and documentation to ensure compliance across all sites.

Designated Individual (DI) Duties

• Ensure tissue receiving, storage, and distribution practices comply with HTA requirements.
• Maintain quality procedures in line with HTA Directions and Codes of Practice.
• Verify imports of human tissues and cells from non-EEA states meet equivalent standards of quality and safety.
• Ensure all tissue licenses are valid and compliant with conditions.
• Maintain establishment activity records and submit annual activity reports to the HTA.
• Record and report Serious Adverse Reactions (SAR) and Serious Adverse Events (SAE) in collaboration with the complaints team.
• Ensure compliance with HTA confidentiality and information requirements.
• Maintain and document annual HTA training, ensuring continuous competency.
• Conduct and update annual risk assessments, addressing any gaps identified.
• Ensure compliance with procedures for receiving, storing, packaging, and shipping of HCT/P (Human Cells, Tissues, and Products).

Responsible Person (RP) Duties

• Ensure human tissues and cells for human applications are procured, tested, processed, stored, and distributed in compliance with applicable EU directives and national laws.
• Provide information to competent authorities for accreditation, designation, authorization, and licensing purposes.
• Support inspections and control measures carried out by competent authorities.
• Maintain full traceability of tissue products, including distribution, end use, and disposal.
• Submit annual activity reports to relevant competent authorities within the EU.
• Notify competent authorities of any Serious Adverse Events/Reactions (SAE/SAR), providing detailed reports on causes and outcomes.
• Ensure recall and SAE/SAR procedures are up to date and effective.
• Verify supplier compliance with donor selection, procurement, and processing requirements under EU Directive 2006/17/EC.
• Maintain and oversee an effective QMS, including SOPs, training, reporting forms, and donor records.
• Ensure staff working with tissue products are qualified and adequately trained.
• Confirm storage, labeling, packaging, and distribution procedures are documented and performed under controlled conditions.
• Ensure agreements are in place with all third parties impacting the quality and safety of tissues, with responsibilities clearly defined.
• Maintain an updated list of third parties, ensuring compliance with EU Directive 2004/23/EC.
• Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensure compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
• Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Required Skills and Experience

• Strong understanding of quality system requirements and compliance trends within the medical device industry.
• Skilled in reading and interpreting safety rules, operating and maintenance instructions, and procedure manuals.
• Excellent communication skills with the ability to effectively engage internal and external stakeholders.
• Proficient in MS Office applications, with strong accuracy in documentation, flow charting, and data graphing.
• Bachelor's degree with a minimum of 5 years of relevant experience, or an advanced degree with no prior experience, or equivalent professional experience.
• Approximately 25% travel required.

Our Life Moves Us Philosophy

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
• Customer Focused: We listen to our customers' needs and respond with a sense of urgency.
• Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
• Driven: We pursue our mission with energy and passion. We are nimble, results‑oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.