Quality Systems Manager

Position Summary:

The QMS Manager is a dynamic, challenging, and high impact role that reports directly to senior leadership. Integral to all aspects of the business, the QMS Manager contributes to project teams, manages the document control process, and ensures ISO and regulatory compliance of the QMS.

Essential Duties and Responsibilities:

Maintains the QMS to ensure compliance to ISO 13485 and 21 CFR 820

Hosts audits of the QMS by customers and regulatory bodies

Owns the document control and training management processes

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 supports the disposition of nonconforming inventory

Supports and coordinates the CAPA process

Provides mentorship and leadership

Identifies opportunities for QMS and work process improvements

Required Education, Experience, Skills and Knowledge:

Minimum 7 years of professional experience

Medical Device experience required

Manufacturing experience required

Document control experience required

Strong understanding of ISO 13485 and 21 CFR 820 and history of maintaining compliance required

Product development experience desired

Single use medical device experience desired

Bachelor’s Degree in Engineering or Technical Field desired

Prior leadership experience desired

Audit hosting experience desired

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

Salary Range:

$86,000 to $120,000 (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).

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