Responsible for the administration, supervision and development of the Quality Assurance and Quality Engineering functions of our client. Ensure full compliance to and International regulations including production and process controls and ISO 13485 requirements. Reports to the General Manager. Works closely with other engineering staff and operations group to provide direction related to GMP, GDP and Management of the QMS.
Job Requirements and Responsibilities:
- Manage the Quality System team and ensure that both regulatory and business requirements are met in the daily running of the department.
- Create a strong collaborative team working environment with focus on customer needs, product quality and compliance.
- Demonstrate commitment to the Quality Policy (product safety and quality) through the daily execution of sound quality practices and the maintenance of an effective quality system.
- Drive continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance to governing regulations and corporate policies and procedures.
- Support audits from external regulatory agencies (Notified Body’s and Competent Authorities) and customers and leads preparation activities in advance of such audits.
- Participate in new product introduction to ensure quality is built into all products early in their life cycle.
- Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
- Participate in Customer Complaint investigations and take appropriate action.
- Manage and provide guidance and/or assist in defining, implementing and follow-up of corrective and preventive actions and supplier corrective action reports, ensure that adequate corrective action is put in place by suppliers and monitor effectiveness of same.
- Provide best in class root cause analysis & problem solving guidance
- Work cross-functionally to deliver on the site strategic targets and objectives.
- Provides direction on Vendor Quality Management strategy and direction for the site.
- Lead investigation of component/material quality issues as they arise – work with supply chain, manufacturing and suppliers to resolve issues and to disposition materials.
- Promoting the Quality System within the Supply Base – working with Purchasing, Supplier Quality Engineering, Receiving Inspection and the business units to ensure that components meet our requirements.
- Proficient in using statistical analysis for analysing data and trends.
- Facilitate and coordinate annual Management Review.
Pre-requisites (Education / Experience / Skills)
- Degree in Quality Engineering / Engineering / Science, or equivalent qualification essential Post graduate diploma / Masters in Quality Management desirable.
- Minimum 7 years work related experience of which at least four years experience is in the medical device manufacturing industry in a similar role, coupled with a proven track record in leadership and development of a team.
- Proven track record in leading organisations through external inspection / audits (e.g. FDA, Notified Bodies, Competent Authorities, Customers), essential .
- Working knowledge of and experience in, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management and Canadian Regulation (CMDR).