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This position is responsible for the overall quality of manufactured medical products. In addition, this role leads initiatives for improved quality and cost saving for existing products. This role offers the opportunity to work with customers, sales, manufacturing, purchasing and quality departments.
Job Responsibility:
Reviews, maintains, and updates the Quality Assurance Manual and other Quality department procedures
Prepares, plans, and leads on behalf of the organization, all external audits both regulatory and customer audits (ISO 13485 QMS) related to the products manufactured onsite
Leads, plans, and implements corrective actions, internal audits to ensure the highest product quality and continuous improvement
Supervises and directs the actions of Quality Inspectors and Quality Engineers. Coaches, counsel and disciplines employees when necessary
Trains employees in the company established work procedures and processes
Works in collaboration with design and manufacturing engineering to implement new products, design changes and to ensure all products and processes meet customer and regulatory specifications
Works cross functionally with all departments to ensure that the organization is aligned with the company's quality policies and meets all regulatory and customer requirements
Works with suppliers to drive corrective actions to maintain a high level of quality. Leads team to manage FAIRs and documentation
Leads and drives till resolution all customer complaints and corrective actions. Maintains and updates customer complaint documentation
The technical lead on incoming and in process inspection equipment selection and calibration requirements
Works with the Director of Quality and Operations to drive total product quality and a spirit of continuous improvement
Requirements:
Bachelor's degree or equivalent experience along with 2 – 5 years of successful supervisory and quality experience in a manufacturing environment
Experience in the medical device field or regulatory environment preferred, EU MDR, FDA GMP & MDSAP
Experience in high pressure flow control valves a plus
Experience with Microsoft Excel, Word, and PowerPoint
Knowledge in machining and other manufacturing processes
Knowledge in Lean Manufacturing, Design for Manufacturing, ISO Quality Systems and 8D Corrective Actions and the PPAP process
Strong problem solving and decision-making skills
Team player with strategic focus
Ability to multi-task several assignments
Ability to manage priorities to ensure timely completion of projects
Good oral and written communication skills
Good organizational abilities, attention to detail
Ability to support efforts for continuous improvements in process efficiency and cost reduction
Self-starter, energizing, results-oriented, and able to multi-task
Excellent cross-functional teamwork, coordination, and communication skills
Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets
Results oriented with a high commitment level
Nice to have:
Experience in the medical device field or regulatory environment preferred, EU MDR, FDA GMP & MDSAP
Experience in high pressure flow control valves a plus
Self-starter, energizing, results-oriented, and able to multi-task
Excellent cross-functional teamwork, coordination, and communication skills
Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets