Job DescriptionJOB SUMMARY:Leads the efforts to identify, investigate, plan, and conduct activities to improve or ensure quality through design and manufacturing of medical devices and components. Leads cross-functionally with R+D engineering, manufacturing, technical service, and supply chain to manage quality, compliance and cost of medical devices and components. Will act as the subject matter expert (SME) on elements within the quality department.
ESSENTIAL/PRIMARY DUTIES:- Ensures that products and product changes comply with all specified regulatory agencies (FDA, ISO, UL, CSA, etc.).
- Creates and assists in developing, maintaining, and improving the Quality Management System (QMS) to ensure compliance to all specified regulatory agencies.
- Drives product quality improvements internally and externally by working with design, manufacturing, and supply chain.
- Acts as a technical lead, manages significant systems, uses strategic planning, and mitigates risk.
- Formulates solutions to complex and ambiguous problems that are not well defined. Incorporates feedback and solutions from others.
- Communicates complex technical ideas through daily work, presentations, and workshops.
- Fosters cross team communication and knowledge sharing. Collaborates with teams and management to make critical technical decisions that align with organizational goals.
- Collaborates with leadership and other cross functional departments to align decisions with organizational goals.
- Champions six sigma techniques and drives standardization through continuous process improvement.
SECONDARY DUTIES:- Identifies and manages Six Sigma projects internal and external to the quality department as well as suppliers.
- Provides leadership, coaching, and/or mentoring to the co-op group and level I, II & III engineers.
- Supports, leads, or manages front room and/or back room for internal and external QMS audits and/or investigations.
- Teaches and provides guidance on engineering documentation such as engineering drawings, bill of materials, change orders, testing documents and DHF/DMR records.
EDUCATION and/or EXPERIENCE:Bachelor's degree in engineering or related field and 6+ years of relevant experience, or equivalent combination of both. Certified Quality Engineer (CQE), Six Sigma Blackbelt and Certified Reliability Engineer (CRE) certifications are preferred.
COMPETENCY and/or SKILL: - Experience in the medical device industry and understanding of medical device quality systems and applications is desired
- Ability to effectively influence and negotiate with all levels of an organization and lead effective/successful change initiatives
- Ability to establish and enforce quality standards that align with industry best practices and regulatory requirements
- Expert problem solver in areas of expertise
- Ability to lead the design of complex, interconnected systems or processes and shape the organization's technical direction
SUPERVISORY RESPONSIBILITIES:- Provides leadership, coaching, and/or mentoring to level I, II and level III engineers.
- May have direct reports of technicians or level I & level II engineers.
