Internal & Supplier Quality Auditor

Olympus Corporation; Southend-on-Sea; Vor Ort; GBP 60.000 - 85.000; Vollzeit

Benefits dieser Stelle

Private medical cover

Pension scheme

Annual health check with BUPA

Employee Assistance Program

Staff restaurant & free parking

Retailer discounts

Zusammenfassung

Olympus Corporation in the United Kingdom seeks an experienced Quality Assurance Auditor to lead external regulatory audits and manage the internal audit programme. You will coordinate ISO 13485, MDSAP, MDR and FDA assessments, drive audit planning and report clear findings.

The role demands strong QMS knowledge, stakeholder collaboration, and a proactive approach to corrective actions and continuous improvement across the organisation.

Qualifikationen

• Experience in Quality Assurance and/or Regulatory Affairs in manufacturing, preferably Medical Device or Pharmaceutical sectors.
• Strong communication skills with the ability to influence stakeholders at all levels.
• Expertise in Quality Management Systems (QMS), quality engineering principles, and regulatory compliance requirements.
• Experience planning, conducting and reporting audits against multiple standards and regulations.
• Self-motivated, able to work independently and prioritise workloads.

Aufgaben

• Support external audits and regulatory inspections (ISO 13485, MDSAP, MDR, FDA).
• Lead and evolve the internal audit programme with robust planning and follow-up.
• Develop and communicate audit schedules to keep teams aligned and inspection-ready.
• Conduct audits delivering actionable findings and drive accountability for outcomes.
• Collaborate with stakeholders to resolve non-conformities and implement corrective actions.
• Analyse audit data to identify risks and provide insight to leadership.
• Champion continuous improvement and drive quality culture across Olympus.
• Share learnings and improvements across the business.
• Enhance audit processes with local and global improvements for compliance.
• Foster quality awareness and a culture of excellence throughout the organisation.
• Collaborate with global process owners to maintain consistent standards.

Kenntnisse

Audit planning

Regulatory compliance

QMS knowledge

Regulatory inspections coordination

Stakeholder communication

Continuous improvement

Ausbildung

IRCA Internal/Lead Auditor Certification

Bachelor's or Master's in Engineering/Manufacturing/Electronics/Biomedical Science

Jobbeschreibung

Your Responsibilities

• Support external audits and regulatory inspections, including ISO 13485, MDSAP, MDR and FDA assessments.
• Lead and evolve the internal audit programme, ensuring robust audit planning, delivery and follow-up across the business.
• Develop and communicate audit schedules that keep teams aligned, informed and inspection-ready.
• Conduct impactful audits, delivering clear, actionable findings and driving accountability for outcomes.
• Partner with stakeholders to resolve non-conformities, implement corrective actions and prevent recurrence.
• Analyse audit data and trends to identify risks, highlight opportunities and provide insight to senior leadership.
• Champion continuous improvement initiatives, supporting quality enhancement projects across the wider Olympus organisation.
• Promote best practice by sharing learnings, success stories and improvement opportunities across the business.
• Drive enhancements to audit processes, implementing local and global improvements that increase effectiveness and compliance.
• Build quality awareness and foster a culture of excellence throughout the organisation.
• Collaborate with global process owners to strengthen audit methodologies and deliver consistent standards worldwide.
• Ensure all activities are carried out in line with regulatory, quality, health, safety and environmental requirements.

Your qualification

Qualifications The Ideal candidate for this role will combine strong technical and regulatory expertise with a collaborative, improvement-focused mindset. Comfortable challenging the status quo, you'll use your auditing experience and quality knowledge to identify risks, drive meaningful improvements and help maintain the highest standards of quality and compliance across the business.

Required Experience

• Proven experience within Quality Assurance and/or Regulatory Affairs in a manufacturing environment, ideally within the Medical Device or Pharmaceutical sectors.
• An exceptional communicator with the ability to influence stakeholders at all levels, both verbally and in writing.
• Strong expertise in Quality Management Systems (QMS), quality engineering principles, and regulatory compliance requirements.
• Experienced in planning, conducting and reporting audits against multiple standards and regulations, with a strong focus on quality management systems.
• Self-motivated and confident working independently, with the ability to prioritise workloads and make informed decisions.
• Qualified Internal or Lead Auditor through an IRCA-recognised programme (or equivalent), with knowledge of ISO 9001 and ISO 13485 standards. Candidates willing to undertake formal auditor training will also be considered.
• Good understanding of MDSAP requirements and the regulatory landscape within the medical device industry.
• A proactive problem-solver who is passionate about continuous improvement, compliance excellence and driving quality culture.
• Degree-qualified in a technical discipline such as Engineering, Electronics, Biomedical Science or Manufacturing (Bachelor's or Master's level).

Your competencies

• Patient Focus - We put patients at the heart of everything
• Integrity - We do the right thing
• Innovation - We look for new ways to make things better
• Impact - We take accountability and get things done
• Empathy - We care for one another and work together

Your Benefits

• In addition to a competitive salary, you will receive a generous annual leave entitlement
• You will be eligible to receive private medical cover
• Comprehensive company pension scheme
• You will receive an annual health check with BUPA, funded by us
• Employee Assistance Program to support your health, mental and emotional-wellbeing
• At our HQ, we have a subsidised staff restaurant and free parking
• Other benefits include discounted gym and wellness memberships, cashback and discounts with major UK retailers

Further Information

We value the diversity of individuals, perspectives, and lifestyles, and prioritise inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.