Quality Manager

April 7, 2023

Position Summary:

The Quality Manager is a dynamic, challenging, and high-impact role that reports directly to senior leadership. Integral to all aspects of the business, the Quality Manager contributes to project teams, ensures regulatory compliance of the QMS, and serves as the functional leader for the Quality team.

Essential Duties and Responsibilities:

• Maintains the QMS to ensure compliance with ISO 13485 and 21 CFR 820
• Hosts audits of the QMS by customers and regulatory bodies
• Manages the document control process
• Works with Product Development to define product requirements
• Oversees design verification and validation activities
• Leads the risk management process in accordance with ISO 14971
• Ensures the accuracy and completeness of documents and records for inclusion in DHFs / DHRs
• Collaborates on compliant and efficient strategies for reaching customer milestones
• Participates in Material Review Board activities and dispositions of nonconforming inventory
• Leads root cause investigations and manage the CAPA process
• Supports process and test method validations
• Provides mentorship and leadership
• Establishes personnel development plans
• Measures performance and holds formal reviews with direct reports

Required Education, Experience, Skills, and Knowledge:

• Medical Device experience required
• Product development experience required
• Bachelor’s Degree in Engineering or Technical Field required
• Prior leadership experience preferred
• Well-versed in ISO 13485 and 21 CFR 820
• Strong understanding of statistical methods and sampling plans
• Excellent aptitude and confidence in customer-facing communications
• Detail-oriented, organized, and diligent in record keeping and Good Documentation Practices (GDP)
• Willing to learn and grow within the organization
• Customer-focused with excellent communications skills, written and oral

Skills Proficiency:

• Demonstrates a strong work ethic, thrives in a collaborative environment, and offers creative and innovative solutions to challenging project deliverables and tight timelines 
• Demonstrates strong aptitude and confidence in customer-facing communications 
• Demonstrates a detail-oriented, organized, and diligent approach to record-keeping and Good Documentation Practices (GDP) 

Salary Range:

$90,000 to $118,000 (25th percentile/90th percentile, PayScale data); Bonus eligible depending on achieving company performance targets.

Benefits:

This position will be eligible to enroll in benefits including health, dental and vision programs as well as AD&D and Long-Term Disability Insurance, 401(k).  Position will accrue 15 PTO days per year and 1 additional day for each year of service (up to 25 days).

Apply to: humanresources@meddux.com