Description:

• Day to Day production line support - Quality and product assurance - Overseeing 2 engineers - Overseeing production staff - Implementation of manufacturing processes - Supports and leads manufacturing process improvements for both internal manufacturing facilities and in partnership with external suppliers. - Refines existing specifications, leads process improvement projects, creates validation testing, and makes product yield enhancements and cost reductions. - Researches and recommends vendor and material choices for product. Prepares and delivers status reports. - Develops and implements quality inspection procedures, including sampling plans, for production level components and finished goods. - Reviews and approves assigned controlled documents (e.g. work instructions, quality specifications, engineering specifications, procedures, and validations protocols). Ensures that product documentation is in accordance with Quality System requirements. - Maintains compliance of quality related logs and records, including but not limited to, CAPA, NCR, ASL and Training. - Establishes, implements, and maintains company Quality System in compliance with FDA, International Standards (ISO), and other regulatory agencies. - Provide assembler/operator training and contribute to the development of support materials as required. - Manages communication and acts as supporting liaison with regulatory agencies on compliance issues, including registration and licensing of facilities and regulatory agency audits and inspections. - May work directly with the company/customer representative to determine needs in product repairs, complaints analysis and user interface.

Skills:

medical device, class iii medical devices, Process improvement, Process engineering

Top Skills Details:

medical device,class iii medical devices,Process improvement,Process engineering

Additional Skills & Qualifications:

• Specific Catheter Experince (like to see people from Medtronic - Supervisory or Management experince

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.