Site Quality Manager

Location: Heighington

Site Quality Manager Blackwood ?

Location:

Blackwood Reporting into:
Head of Quality

Shift: Full time Join us in protecting health and improving lives ? Are you an experienced Site Quality Manager ready to take ownership of a critical quality function within a purpose-driven healthcare organisation? ? At Vernacare, our Site Quality Managers play a vital role in protecting patient safety, supporting healthcare professionals, and driving sustainable manufacturing. As a Site Quality Manager, you will be at the heart of ensuring our products meet the highest regulatory and quality standards while shaping the future of our Blackwood site.

? Why This Site Quality Manager Role Matters ? This Site Quality Manager position is not just another quality roleit's an opportunity to:
Act as the Quality Management Representative (QMR) for the site Influence strategic quality decisions at senior leadership level Lead and develop a high-performing quality team Ensure compliance across a regulated medical device manufacturing environment Drive innovation and continuous improvement across the business ?

The Role:

? As our Site Quality Manager, youll act as the Quality Management Representative (QMR), leading the development, implementation, and continuous improvement of the Quality Management System (QMS) at our Blackwood site. ? Youll play a pivotal role in ensuring compliance with ISO standards and regulatory requirements, while driving a culture of quality excellence across the site. ? ________________________________ ?

Key Responsibilities:

? As our Site Quality Manager, you will: ? Leadership & Team Management Lead, coach, and develop the site Quality Assurance team Build a culture of accountability, collaboration, and continuous improvement Mentor team members on quality best practices and regulatory standards Quality Management System (QMS) Ownership Own, maintain, and continuously improve the site QMS Ensure alignment with ISO 9001 / ISO 13485 and regulatory requirements Maintain and evolve QMS documentation, processes, and procedures Compliance & Regulatory Leadership Act as the primary point of contact for quality and compliance Manage relationships with Notified Bodies and regulatory authorities Ensure ongoing compliance for CE-marked medical devices Audits, Reporting & Continuous Improvement Plan and lead internal audits and external audit readiness Manage and host customer and regulatory audits Deliver quality performance reporting and annual management reviews Identify trends, risks, and opportunities for improvement Cross-Functional Collaboration Partner with R&D, manufacturing, and regulatory teams Support New Product Development (NPD) activities with quality input Contribute to design control, validation, and change management Support supplier quality and process validation initiatives ?

________________________________ ?

What Were Looking For : ? To be Successful as our next Quality Manager at our Blackwood facility, you'll ideally have the following skills, experience and personality. ?

Experience:

? Proven track record as a Site Quality Manager or senior Quality professional Minimum 5 years in Quality Assurance within medical devices At least 2 years of leadership/line management experience Experience working with ISO standards and regulatory frameworks Strong involvement with New Product Development (NPD) Experience interacting with Notified Bodies and Competent Authorities ?

Qualifications:

? Degree in Engineering, Life Sciences, or related discipline Ongoing professional development in Quality or Regulatory fields Certifications (e.g. Six Sigma, ASQ) highly desirable ?

Skills:

? Excellent leadership and stakeholder engagement skills Strong analytical and problem-solving capabilities High attention to detail and compliance-driven mindset Ability to influence at all levels and work cross-functionally ? Personal Attributes: ? Resilient, adaptable, and proactive Strong communicator who can simplify complex information Passionate about delivering quality and improving healthcare outcomes ? ________________________________ ? Our Values The C.A.R.E Framework ? At Vernacare, everything we do is guided by…