OVERVIEW:

MedComp is a leading developer and manufacturer of vascular access products specializing in the field of interventional medicine, dialysis, and oncology. We are committed to providing innovative, quality products for hemodialysis, peritoneal dialysis, drainage, and infusion needs to positively impact the patients and clinicians who utilize them.
If you have been looking for a role where your contribution will matter, this is it. We will provide YOU with the opportunity to be part of a team that develops, enhances and supports products that truly make a difference in the life of the patients we serve.

SUPERVISORY RESPONSIBILITIES:

Directly supervise QA professionals at Martech and Medcomp locations, excluding Yuma location. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include, approving/denying PTO requests, tracks PTO, interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Our offerings have our Team Members well-being in mind.

• Hybrid environment after six months – 4 days in office and 1 day remote
• Competitive compensation
• Health, Dental, Vision coverage

Essential Duties & Key Responsibilities:

• Standardize Quality Management Systems across multiple businesses, including establishing Corporate Policies, SOPs and the Quality manuals.
• Ensure continued compliance with FDA, ISO 13485, MDSAP countries, EU MDD &MDR requirements and other applicable regional and international regulations.
• Support preparation activities for and participate in regulatory inspections/external audits (Notified Body and Customers).
• Actively monitor processes for compliance with Corporate Policies, procedures, and relevant regulations.
• Subject Matter Expert (SME) for QMS processes.
• Identify and mitigate risks related to product quality and regulatory compliance.
• Analyze QMS process effectiveness and identify gaps or areas for improvement.
• Develop, monitor, maintain and report on Quality Key Performance Indicators (KPI).
• Identify compliance gaps and lead focused teams to resolve compliance issues.
• Provide recommendations for continuous improvements to Senior Management, support improvements of the QMS and other business processes as needed.
• Support New Product Development (NPD) initiatives.
• Lead and manage QMS functions: Change Control, CAPA, Document Management, NCR, Variances and others as applicable.
• Write and revise SOPs, controlled forms, and related documents to ensure best practices and compliance with the regulations.
• Prepare, Coordinate, and lead Quality Systems Management Review.
• Develop QMS training material and conduct training to improve employee understanding of the QMS and associated processes.
• Manage and mentor a team of quality assurance professionals.
• Support Distribution Center resolving potential nonconformances and improve processes.
• Perform other duties as assigned