Quality Assurance/Quality Control Manager

Position Summary :

• The QA / QC manager is responsible for ensuring that the Quality Management System (QMS) is fully implemented and maintained in an organized and efficient manner;
• is responsible for delegating and assigning tasks to QA team and working closely with QC Supervisor; will report and work closely with Global RA / OA Director 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;

will assist and support in continuous improvement efforts and defect reduction initiatives to establish an effective QMS.

Essential Duties and Responsibilities :

• Manage and oversee project quality to ensure compliance to standards, regulations and QMS requirements .
• 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 / QC Department production schedule.
• Provide support as Quality Management System to Bradshaw Medical.
• Work with Global RA / QA Director 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 Global RA / QA Director 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.
• Planning duties within the QA / QC staff and related work schedules.
• Providing leadership, mentorship, and direction of all QA / QC personnel
• Taking full responsibility for hold-point releases once all QMS functions.
• Identify and develop solutions to correct inspection function deficiencies.
• 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' working experience and knowledge in Quality Assurance / Quality Control 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).
• Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor.

Job Posted by ApplicantPro