Medical Quality Manager

1 week ago

Spartanburg, United States Techtronic Industries - TTI Full time
Job Description:

Techtronic Industries is a fast-growing world leader in Power Tools, Accessories, Hand Tools, Outdoor Power Equipment, and Floor Care for Do-It-Yourself (DIY), professional and industrial users in the home improvement, repair, maintenance, construction, and infrastructure industries. The Company is committed to accelerating the transformation of these industries through superior environmentally friendly cordless technology. At TTI Anderson, our brands RYOBI and HART are recognized worldwide for their deep heritage and cordless product platforms of superior quality, outstanding performance, safety, productivity, and compelling innovation.

JOB SUMMARY

A Quality professional responsible for providing leadership in Quality Control and quality support services by ensuring the company meets or exceeds customer requirements during the assembly of medical devices. This position is held responsible for the quality and reliability of products, and processes by planning and supervising the activities of Medical Quality Control group.

RESPONSIBILITIES / SKILLS
  • Ability to motivate teams and manage through influence and is comfortable working with hourly associates as well as presenting to executive level managers and leaders.
  • Responsible for gathering data and authoring reports to indicate progress towards company goals.
  • Responsible for improvements to the production line quality process, incoming inspection, and procedures.
  • Ability to manage 3-6 direct reports by developing and maintaining consistent methodology for compliance and continuous improvement.
  • Conducts training on quality control concepts and tools.
EDUCATION AND EXPERIENCE
  • Bachelor's in engineering, life sciences, or related field required.
  • 4+ years' experience as a quality professional within an FDA regulated environment.
  • Candidate must be a self-directed, detail-oriented, dependable, and trustworthy person who works well independently, while being highly motivated.
  • Strong written and verbal communication skills, with a sense of urgency and accountability.
  • Experience in leading continuous improvement activities through the CAPA and Internal Audit Program.
  • Proficiency in Microsoft suite (PowerPoint, SharePoint, Word, Excel, Outlook, Teams, OneNote) required.
  • Experience interacting with Senior Management.
  • FDA 21 CFR 820 and ISO 13485 knowledge required.
OTHER REQUIREMENTS
  • Professional certifications through ASQ - CQE, CQA
  • Experience with Minitab a plus
  • Experience with SAP a plus


PHYSICAL REQUIREMENTS:

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 30 pounds at times.

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