Head of Quality & Regulatory Affairs-IS0 13485-£60k-£65k-Essex
Head of Quality & Regulatory Affairs-IS0 13485-Microbiology - £60k-£65k + Bonus - Essex
A growing medical device manufacturer requires an experienced QA/RA professional to join them as Head of Quality & Regulatory Assurance. Reporting to the CEO, you will be a part of the senior management team of an expanding business. You will have significant experience within QA and regulatory Affairs within the pharmaceutical or medical device industries and have proven leadership skills.
This role requires you to very much remain hands-on as the company grows and help develop and improve the current QMS and regulatory processes.
As Head of Quality Assurance and Regulatory Affairs you will be involved in all aspects of the Quality Operation including:
*Direct and coordinate the company's quality program, including ISO13485/FDA QSR systems and procedures.
*Ensure knowledge is kept up to date on all industry best practice and FDA or regulatory requirements
*New Product and Process Introduction
*Process Validation, Statistical Analysis & Capability Studies
*Generation and maintenance of QMS Documentation/MDD Technical files.
*Product / Process / cGMP Training & Training Records
*Internal / Supplier / Customer and Notified Body Audits
*Routine Inspection and measurement.
*Liaising with Suppliers and Customers - Complaint Investigations & reporting
*Root cause Analysis and Corrective & Preventive Actions
*Implementation of Lean principles (Identification & elimination of Waste)
*Implementation of Six Sigma principles (Identification & elimination of Variation)
*A working knowledge of the ISO 9001:2008, 13485:2003, standards, FDA QSR, and the Medical Device Directive, ideally with previous experience of working in a senior quality role within the Medical Devices or Pharmaceutical Industry.
*Experience of influencing people with a demonstrable track record of making a difference within an organisation.
*Excellent understanding of customer relationship management and customer service
*Excellent people skills
*Good IT Skills using Microsoft Office
*Excellent numerical reasoning skills
*Excellent Team working, verbal and written communication skills.
*Experience in Product and Process validation, Statistical analysis and process capability studies.
*A qualification or experience in Auditing
*A working knowledge of Kazan, Six Sigma, Lean, Problem solving, Continuous Improvement methodologies, tools and techniques.
*Experience in CA PA management and change control
*Validation experience including CV.
*Extensive experience in Quality Systems management.
This is a permanent opportunity offering a challenging and long-term career. Salary is £60k-£65k + c.20% bonus
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