Quality Assurance Manager - Biotechnology
Exciting opportunity to lead Site Quality Management System
Work towards driving better lives and a better planet
About Our Client
Our client is a global leader in high-tech filtration, separation, and purification; thriving on helping their customers protect people.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations.
- Devises strategies for compliance, and liaison with regulatory bodies.
- Investigates and assists in resolution of compliance problems and questions;
- Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes.
- Prepares regulatory submissions, negotiates the resolution of agency questions, and secures market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products.
- Executes appropriately on product recalls. Respond to regulatory agency inquiries.
- Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
- Conduct internal management Review and action plans
- Maintain the Site Quality Manual System according the actual ISO Norm 2001:2015
- Responsible for monitoring, calculation and monthly reporting of Key Quality Assurance
- Performance Indicators and the Project Performance Analysis
- Optimally support the Site and Global Supplier Management Process
- Contribution/Assistance/Execution of Customer audits on site
- Responsible for training the Pall Westborough group and support the Training in quality systems requirements, policies and procedures
- Responsible for administrating, coordinating and maintaining the QMS documentation in compliance with current QMS ISO standards
- Completion of customer responses to questionnaires
The Successful Applicant
- Bachelor's Degree Level (i.e. mechanical / process / plant engineering);
- In-depth knowledge of Quality Assurance in Engineering and the Process Industry;
- Excellent cross-level communication skills;
- Analytical and structural thinking;
- Technical flair/knowledge of system devices used in the pharmaceutical;
- Customer orientated
What's on Offer
- Competitive base salary and attractive benefit package