Senior Quality Engineer

Midmark Corporation; Versailles (OH); On-site; USD 85,000 - 105,000; Full time

Job summary

A leading medical device company in Versailles, Ohio, seeks a Quality Manager to oversee quality systems and ensure regulatory compliance. This position involves driving product quality improvements, managing cross-functional teams, and mentoring engineering staff. The ideal candidate holds a degree in engineering, possesses 6+ years of relevant experience, and has certifications like CQE and Six Sigma Blackbelt. This role offers a dynamic opportunity to shape quality practices in healthcare technology.

Qualifications

• 6+ years of relevant experience in the medical device sector.
• Leadership abilities for engineers and technicians.
• Experience with Six Sigma projects and quality management systems.

Responsibilities

• Ensure compliance with regulatory agencies like FDA and ISO.
• Develop and maintain the Quality Management System.
• Drive continuous process improvement and product quality.
• Lead cross-functional teams in technical decision-making.

Skills

Medical device industry experience

Understanding of medical device quality systems

Leadership and mentoring

Problem-solving

Influencing and negotiating

Education

Bachelor's degree in engineering or related field

Certified Quality Engineer (CQE)

Six Sigma Blackbelt

Certified Reliability Engineer (CRE)

Job description

JOB 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.

About Us

Founded in 1915, Midmark Corporation is the only company transforming healthcare experiences through innovative design within the medical, dental and animal health environments. With more than 2,200 teammates worldwide, Midmark focuses on harmonizing space, technology and workflows, creating a better experience for caregivers and patients at the point of care. The Midmark headquarters and innovation hub are located in Versailles, Ohio, which is also home to the Midmark Experience Center, Design Center, Technology Center and our largest manufacturing facility. Midmark maintains eleven additional locations in the United States, including four innovation hubs, and has subsidiaries in India and Italy.

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