The Quality function oversees the development of quality standards and protocols for quality assurance testing models. Quality assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. Interact with customers and provide support for Engineering, Quality Systems and Process engineering.
- Manages, plans, coordinates, and directs quality control program designed to ensure continuous production/service consistent with established standards.
- Manage group of technical staff in required discipline (including staff assignments/workload, HR interface, training, and performance reviews)
- Quality Control Supervisor/Administrator may report to this position.
- Manages the development and analysis of statistical data and specifications to determine present standards and establish proposed quality and reliability expectancy.
- Formulates and maintains quality control objectives and coordinates objectives with production procedures in cooperation with other managers to maximize quality, reliability, and minimize costs.
- Manages, through intermediate personnel, workers engaged in activities to ensure continuous control over materials, facilities, services, and products.
- Develops and implements methods and procedures for monitoring work activities, such as preparation of records of expenditures, progress reports, etc., in order to inform management of current status or work activities.
- Plans, promotes, and organizes training activities related to quality and reliability.
- Analyzes and resolves work problems, or assist employees in solving work problems.
- May recruit, hire, train staff, evaluate employee performance, and recommend or initiate promotions, transfers, and disciplinary action.
- Interprets company policy to employees and enforces company policy and practices.
- May investigate and adjust customer complaints regarding quality.
- Contribute to the development of projects as technical leader in required discipline
- Mentor staff as needed
- Complies with all work rules including those pertaining to safety, health, quality, QSR’s and the Quality Management System
- 7 – 9 years experience in manufacturing, preferably medical devices, with increasing responsibility.
- BS Engineering preferred
- Must be familiar and understand recognized regulatory standards such as ( where applicable)
- Validation experience including IQ/OQ/PQ.
- Experience writing control plans, master validation plans, SPC (Minitab), statistical sampling plan and protocol development
- New Product Development (NPD) experience, Concept to Commercialization
- Excellent customer interface experience.
- US – CFR 21 part 820 (FDA QSR, GMP)
- ISO 13485 – (EN) ISO 13485
- 93/42/EEC (MDD) Medical Device Directive
- 90/385/EEC (AIMD) Active Implantable Medical Device Directive
- 98/79/EC (IVDD) In Vitro Diagnostic Medical Device Directive (
- ISO 13485 under Canadian Medical Device Conformity Assessment System (CMDCAS)
- ISO 14971 – Application of Risk Management to Medical Devices
- AS9100 – Quality Management Systems for Aerospace & Defense Industries
- ISO 9001 – Quality Management Systems Requirements
- Strong technical knowledge in required discipline
- Must be fluent in use of computer systems for the analysis of data, specifically Microsoft office and Statistical packages.
- Familiarity with MRP, SPC, Geometric Tolerencing and mechanical drawings.
- Must possess excellent verbal & written communication skills, as well as presentation, organizational and management skills.
- Experience with plastic injection molding and medical device assembly a plus.
Bachelor’s Degree in Engineering or related field required
SKILLS / COMPETENCIES
- Oracle or ERP data entry preferred
- Competence in the selection and use of Quality Engineering Tools and Techniques.
- Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
- Proficient in Microsoft Office and Minitab