Quality Engineering Director

at  Smith Nephew

Role Title
Quality Engineering Director
Location
Hull, UK
Rewards
Competitive salary and comprehensive benefits on offer
Summary
This position will be responsible for managing the Quality engineers and supplier quality teams for the manufactured/PFG (purchased finished goods) product, in a compliant and cost-effective manner, whilst complying with company Quality Systems, regulatory and statutory Health & Safety requirements and Site Safety Policy.
It will be focussed on line management of the team and additionally it will be important to maintain a close working relationship with all QA/manufacturing functions across the site to ensure customer service levels are reached. To effectively coach and develop the department to provide continuous improvement of business results, individual and team performance.

Essential Job Functions

• To proactively manage and develop the performance of team members through performance management, training and development to meet the business needs and objectives.
• To establish and maintain documented processes to ensure that product disposition and release of compliant product are performed within agreed lead-times.
• To work with the In-Process control team based in the Hull Site factory to ensure that quality system activities, such as complaint, CAPA, deviation and non-conforming product investigations are satisfactory and performed within agreed lead-times.
• Ensure compliance to relevant GMP/GDP and Quality Systems standards, specifically FDA Regulations, MDD and ISO 13485.
• Manages and maintains the quality inspection and product release programs for in-process materials and components, processes and finished goods.
• To prepare and submit reports of departmental measure of appropriate quality to internal management and external bodies, as required.

Requirements

• Ideally educated to degree level in a quality, science, engineering or business management based discipline or has equivalent work experience in relevant area.
• Experience as a line manager and working with teams
• Background within a Quality Assurance department, ideally within the Medical Device / Pharmaceutical Industry.
• Awareness / understanding of company products, processes, procedures and personnel.
• Detailed knowledge and experience of the GMP and Quality Standards, which are applicable to the site and suppliers of goods and services, including ISO 9001, ISO 13485, FDA QSR & Japanese PAL. Detailed knowledge of their application of EU harmonised standards and global guidance documents.
• Working knowledge of related standards and regulations.
• Strong analytical and good communication skills are essential together with the ability to manage personal and team workloads to ensure high standards are maintained.
• Lead audit trained in ISO13485:2016 preferred
• Lean Six Sigma Greenbelt certification preferred
• Excellent analytical, strategic and communication skills are essential together with the ability to communicate effectively across all professional levels within the business
• Strong technical background and problem-solving skills.
• At least 8 years’ experience in the medical devices industry with significant involvement in Quality Assurance and development and execution of strategic imperatives

About Us
Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.

We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:

• Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
• Advanced Wound Management - wound care treatment and prevention products used to treat hard to heal wounds
• Sports Medicine - minimally invasive surgery of the joint
• Trauma & Extremities - products that help repair broken bones

We have over 16,000 employees around the world. Annual sales in 2016 were more than $4.6 billion.
We are a constituent of the UK’s FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN) .
Applications
If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you.
We continue to actively build an environment where every individual can fulfill their potential and be proud ambassadors for Smith & Nephew, our customers and their patients. We value the diversity of our people and welcome applications from everyone.
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Please refer the Job description for details