McKesson Quality Assurance Manager in Munster, Ireland
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. McKesson Medical-Surgical provides medical-surgical supplies and equipment to physicians' offices, home care agencies, long-term care facilities and surgery centers. Our catalog includes more than 150,000 national brand products from bandages to exam tables, plus McKesson's own line of high-quality medical-surgical products. We're proud to be the only national distributor serving the entire continuum of healthcare.
Every single McKesson employee contributes to our mission—by joining McKesson Medical-Surgical you act as a catalyst in a chain of events that helps millions of people all over the globe. Your expertise, drive and passion can help us improve everything we touch, from providers to payors to pharmacies. You’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
Join our team of leaders to begin a rewarding career.
This role will be responsible for creating a quality system for the importation of medical devices into the EU. This includes achieving ISO 13485 certification, obtaining CE Marking for our products, and implementing the necessary quality check for the products to be imported. The Quality Assurance Manager will be the interface between the Asian manufacturers and key customers for quality related issues, including factory audits.
Responsibilities include, but are not limited to, the following:
Create and maintain the necessary Quality System for importation of medical devices into the EU.
Achieve ISO 13485 certification for the company and obtain CE Marking for our products.
Ensures EU product and packaging specification meet EU and country specific directives
Review all product technical specifications based on EU and country specific category directives
Confirm all claims which can or must be used on package for each market and has responsibility for CE marking compliance
Maintain QA documentation in accordance with cGMP (current Good Manufacturing Procedures) and ISO 13485 standard requirements.
Overall responsibility for operations as outlined above.
Manage the investigation of non-conformances and complaints, as requested by corporate headquarters and key customers; investigate non-conformances and complaints with vendors resulting in a reduction of future occurrences.
Perform product inspections and in factory quality audits on occasion.
Approve all procedures, specification and technical files that are needed for our products.
Review and approve validation protocol and reports, study protocol and reports.
Manage the change control system and initiate and implement change control procedures as required.
Manage a variable workload to meet operational requirements.
Ensure that all Health, Safety and Environmental requirements are fulfilled.
Create & maintain a culture of total quality & continuous improvement throughout the organisation.
Plan and manage the requirements and priorities of major objectives.
Analysis and resolution of moderately complex management or technical problems.
Operational responsibility for Legal reviews.
Ensure a safe and productive workplace where legislative and commercial obligations are consistently met.
Initiates/approves changes to systems, programs, products, policies to ensure consistency with company philosophy and culture.
Approve functional division budget/operating costs.
- Bachelor’s Degree in engineering/sciences (biology, chemistry, etc) or equivalent experience.
- 10-12 years experience in medical device quality assurance and FDA/EU regulatory. 5 years managing people.
Knowledge and Skills
Experience using an electronic Quality Management System (QMS) or QMS software i.e. MasterControl.
Knowledge of European and FDA regulations, coupled with an understanding of relevant directives, standards, policies and guidelines and the ability to implement appropriately is also required.
Strong communication skills with ability to communicate at all levels within the organization.
Ability to work effectively with others to accomplish goals.
Ability to explore options and make appropriate choices to support the business.
Understanding of customs and beliefs of other groups or cultures.
Excellent Organisational, problem solving skills and attention to detail.
Self motivated, results orientated individual.
Leadership/ Management experience.
Ability to manage and direct the quality function team.
- Proficient in MS Excel & Word. Database familiarity would be advantageous.
Job: Distribution Operations
Organization: McKesson Corporate
Title: Quality Assurance Manager
Requisition ID: 17002831