Manufacturing Quality Manager
Educated to degree level or equivalent in Quality, Engineering or Science
Knowledge of FDA, ISO 13485 and other regulatory country specific standards
About Our Client
Acelity is a global advanced wound care provider, with a team of nearly 5,000 people around the world. We serve 90 countries across the globe from Gargrave with products that are designed to deliver superior clinical outcomes for patients. Our products save lives and lead the industry in quality, safety and customer experience.
The Systagenix site in North Yorkshire is a centre of excellence for a number of functions with strong links to local colleges and universities.
Situated on the edge of the beautiful Yorkshire Dales just off the A59 near Skipton, we are passionate about attracting the best talent and committed to providing career progression opportunities.
- Is viewed as a leader in the areas of QSR, ISO/MDD and other country specific standards.
- Consistently promoting awareness of best industry practices and making appropriate decisions on a daily basis.
- Takes a leadership role in developing and implementing new techniques and initiatives to enhance the Quality Management System on site and across the Corporation where relevant.
- Is key to developing staff on new quality initiatives and assists understanding and rollout of quality initiatives across the site.
- Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the site strategic objectives.
- Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
- Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
- Manages and provides technical guidance to Quality Engineers, Quality Team Leads and Quality Technicians / Specialists.
- Leads all external regulatory audits in areas of their responsibility.
- Provides guidance on completion of non-conforming material reports, deviations & change orders.
- Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
- Supporting regulatory submissions requirements to RA in Gargrave and San Antonio.
- Provides guidance to Engineers, Quality Engineers and Manufacturing support personnel on areas that need to be covered for various types of qualification/validation.
- Active management within Project Teams to identify quality requirements.
- Maintain and update site quality metrics.
- Complaint investigation and coordination as relevant for the Gargrave site.
- Product Release
- Will abide to Environmental, Health and Safety (EHS) Policies.
The Successful Applicant
- Degree in Quality, Engineering, Science or related subject.
- A minimum of 10 years' experience in a medical device / pharmaceutical regulated environment.
- Thorough knowledge and understanding of FDA, ISO 13485 and other regulatory country specific standards.
- Sets Direction
- Drives Innovation & Change
- Inspires Others
- Promotes Teamwork
- Develops Self and Others
- Knows the Business
What's on Offer
This role is paying £45,000**
Private health care
25 days holiday + bank holidays
finish at 1pm every Friday
Free Gym on site
**dependent on experience