The QA manager will help the Director of QA/RA manage and update the Quality Management System (QMS) to ensure that FDA regulatory and ISO 13485 requirements are met, product quality is in conformance with the regulations, and that the customer’s requirements are met. Asist and support in continuous improvement efforts and defect reduction initiatives to establish an effective QMS.
Essential Duties and Responsibilities:
· Coordinate quality activities by supervising staff; organizing and managing production schedules, monitoring work flow and expediting work as necessary.
· Works closely with the Operations management to identify potential quality issues before they arise and take preventative actions to prevent problem occurrence.
· Monitors and analyzes job results and recommends actions as necessary to improve performance.
· Performs required administrative tasks including preparation of required reports and correspondence.
· Works closely with Production Management and Materials Management to develop, communicate and supervise the QA Department production schedule.
· Provide support as Quality Management System representative backup.
· Work with Director of QA/RA to sustain and lead improvement to the Quality Management System, develop and implement Quality policy, plans and procedures, and drive continuous improvement and provide leadership and project management.
· Work with the Director of QA/RA to improve the customers and supplier’s relationship regarding standards for precision, capability, quality and on-time delivery.
· Researches, investigates, and tests new methods, technologies, equipment, and systems in the fields of quality, inspection, and manufacturing that will improve the overall levels of performance in manufacturing inspection and testing.
· Critical thinking skills a must and capable of coaching, developing, and using key quality principles for trouble shooting and root cause analysis such as 5-whys, cause and effect, Pareto analysis and validated root cause to identify effective corrective actions and process improvements.
· Communicates status updates and improvement plans to all departments and management teams.
· Works cohesively with the Director of QA and Regulatory department regarding audits, non-conforming product, CAPA’s, SCAR’s, Complaints, etc.
· Partner with General Manager to drive the resolution of customer driven issues including product complaints, rework, specifications, and processes impacting lead time.
· Monitors vendor performance and the establishment of criteria and rating system for critical vendors.
· Active lead in internal and external quality audits to ensure compliance and successful results.
· Follow up on defect trends – meet with responsible managers, develops improvement plans, provides historical data, etc. Documents non-conformances and facilitates a timely disposition.
· All other duties as assigned.
Knowledge, Skills & Competencies:
- 5 + years’ experience in Quality and/or Regulatory in a manufacturing environment within the medical device industry, quality control, and risk management, supplier audits, CAPA and complaint handling.
· Critical thinking skills and experience coaching, developing, and using key quality principles for trouble shooting and root cause analysis such as 5-whys, cause and effect, Pareto analysis and validated root cause to identify effective corrective actions and process improvements.
- Prior experience leading a quality team.
- Previous experience in a machining environment required.
- Knowledge of raw materials and production processes.
- Sound understanding of the principles of the various products.
- High energy and results-oriented individual who is successful in a business environment and is skilled in motivating and inspiring people.
- Mid-size company “hands on experience”
- Knowledge and understanding of medical device regulations and quality concepts (21CFR FDA 820) and ISO 13485.
- Ability to identify complex problems and review related information to develop and evaluate options and implement solutions.
- Ability to communicate effectively in multi-discipline, cross cultural environment and levels of organization.
- Knowledge and experience in the implementation of Continuous Process Improvement, Lean and Six Sigma.
- Capable of handling stressful situations and manage conflict.
- Computer literate in various software applications (i.e. Microsoft Office).