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Quality System Manager
2 months ago
Join Our Team as a Quality System Manager
Are you passionate about quality management and compliance in the medical device industry? Do you thrive in a strategic role that impacts company-wide operations? If so, we have the perfect opportunity for you
Position Summary:
We are seeking an experienced and dynamic Quality System Manager to lead and enhance our Quality Management System across multiple sites. This critical role will ensure our operations meet the highest standards of quality and regulatory compliance. Reporting to executive management, you will play a key
Quality Management: Maintain and enhance the Quality Management System to support daily operations and ensure compliance with necessary standards.
Collaboration: Work closely with department managers to develop and enforce quality procedures and work instructions.
Audits: Oversee internal and supplier audit programs, ensuring effective reporting and corrective actions.
Regulatory Compliance: Maintain FDA regulatory, domestic, and international filings, and serve as the primary interface with regulatory agencies.
Continuous Improvement: Monitor quality information, recommend improvements, and implement process enhancements.
Communication: Act as a liaison between internal and external stakeholders, ensuring clear communication regarding quality standards and compliance.
*What we're looking for:
Education: Bachelor’s Degree preferred.
Experience: 5+ years of related experience, particularly with the FDA and regulatory agencies.
Expertise: Proficiency in quality management software, enterprise database programs, and technical writing.
Skills: Strong analytical, mathematical, and communication skills.
Industry Knowledge Experience in Medical Device manufacturing and QSR, with preferred experience in a Class II Medical Device environment.
Physical and Mental Demands:
Ability to handle moderate to high stress levels.
Regularly required to sit, stand, move, and lift up to 50 pounds.
Proficiency in reading and interpreting technical documents and using computer systems.
Certificates and Licenses:
Professional certification in Quality Engineering preferred.
Membership in ASQ and/or RAPS is desirable.
Supervisory Responsibilities:
Lead and develop a team of quality professionals.
Ensure high morale and productivity through effective management and coaching.
Work Environment:
Our work environment varies between a typical office setting and on-site visits, with reasonable accommodations provided to support all team members.
*This company is an Equal Opportunity Employer: All Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
**This company is a participating E-Verify employer
Company DescriptionDME Medical Device Manufacturer RetailerCompany DescriptionDME Medical Device Manufacturer Retailer