Quality and Compliance Manager

Position Summary

The Quality Manager is responsible for leading the organization's quality assurance and compliance programs, ensuring that all products and processes meet or exceed customer, ISO, regulatory, and statutory requirements. This role oversees the Quality Management System (QMS), drives continuous improvement initiatives, manages internal and external audits, and serves as the primary representative for quality-related matters with customers, vendors, and regulatory bodies. The Quality Manager fosters a culture of excellence, accountability, and ongoing improvement throughout the organization.

Essential Functions

Quality Assurance & Compliance

• Plan, direct, and coordinate quality assurance programs; formulate quality control policies.
• Oversee and maintain the Quality Management System (QMS), ensuring compliance with ISO 9001/13485, FDA, and other relevant standards.
• Monitor performance of quality control systems to ensure effectiveness and efficiency. Review and update SOPs and quality manuals.
• Oversee facilitation of change control process for documented information; ensure change control is followed and meets QMS requirements.
• Ensure customer requirements are determined, reviewed, and managed through the QMS.
• Oversee external standards and customer health/safety communication requirements.

Corporate Quality Improvement

• Monitor for trends that could lead to quality issues and opportunities for process improvements.
• Collaborate with cross-functional teams to determine actions, resource needs, and timeframes.
• Support process/project improvement teams as needed.
• Verify/validate resulting changes; ensure supporting documentation is updated and communicated.

Corrective Actions, Nonconformities & Continuous Improvement

• Lead root cause investigations for process and product nonconformities, using methodologies such as 8D, PFMEA, Six Sigma.
• Manage and verify the effectiveness of corrective and preventive actions (CAPA). Accountable for the corrective action process.
• Implement processes/tools for reporting nonconformities; ensure root causes are investigated, documented, and appropriate corrective actions are taken.
• Analyze quality control test results and provide feedback to production management or staff.
• Drive continuous improvement initiatives to enhance operational efficiency and quality performance.
• Verify completion of corrective actions according to documented timelines; report results to customers, registers, and regulatory bodies.
• Evaluate effectiveness of all corrective actions.

Audits & Documentation

• Schedule and facilitate internal and external audits; ensure timely closure of audit nonconformities.
• Ensure compliance to QMS management review reporting of inputs/outputs; facilitate management review meetings and maintain Business Risk Register.
• Represent the organization in external/customer audits.
• Ensure the QMS is documented and effective; report on the health of the QMS and related processes.
• Prepare, review, and maintain accurate documentation of compliance activities, including complaints, investigations, and audit outcomes.
• Responsible for implementing and monitoring management review process, quality policy, and quality objectives.

Customer & Vendor Interaction

• Serve as the organizational representative for quality-related matters with customers and vendors.
• Access customer portals to retrieve, enter, and update quality-related information, including the completion and submission of supplier surveys, scorecards, and compliance documentation as required by customers.
• Collaborate with customers and vendors to resolve quality issues/complaints, communicate corrective actions, and support supplier quality improvement initiatives.
• Ensure timely and accurate response to customer requests for quality data, corrective actions, and audit documentation.
• Collaborate with suppliers to ensure quality requirements are met; support supplier quality improvement initiatives.

Training & Support

• Train and mentor personnel on quality standards, procedures, and QMS documentation.
• Develop and implement quality training programs for employees.
• Foster an environment where quality standards are understood, valued, and consistently upheld.
• Lead and/or delegate the development and revision of work instructions and forms.

Education and Experience

• Bachelor's Degree required; preferred in a technical field 
• Must be a certified ISO 9001/13485 Internal Auditor 
• Previous supervisory or management experience required 

Knowledge, Skills, and Abilities

• Strong understanding of quality assurance principles, methodologies, and regulatory standards (ISO 9001/13485)
• Proficiency in continuous improvement methodologies such as Lean, Six Sigma, etc.
• Analytical and problem-solving skills to identify trends, address nonconformities, and drive corrective actions.
• Excellent communication, organizational, and leadership skills.
• Strong proficiency in MS Office applications and digital quality management systems.
• Ability to work well under pressure (perform several tasks concurrently) 
• Strong interpersonal skills 
• Ability to work in a team environment. 
• Strong organizational skills 
• Must be confidential, ethical, and trustworthy. 

Key Performance Indictors

• Number of issues (complaints and nonconformities) 
• Number of incidents (recordable and reportable) 
• Findings from customer audits responded to and accepted in a timely manner.

Physical Requirements/Working Conditions 

The physical demands described represent those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand, walk, climb, stoop kneel, and crouch. The employee is occasionally required to balance or crawl. 

The employee is required to regularly reach with arms and hands; use hands to handle, finger or feel objects, tools or controls. Hands and fingers frequently perform repetitive motion. Occasionally the employee will use arms and hands to balance and climb. 

The employee must frequently lift and/or move up to 25 pounds. Occasionally the employee will lift and/or move up to 50 pounds. The employee will occasionally lift and/or move up to and over 100 pounds with the help of equipment.

This job requires close vision, peripheral vision, depth perception and the ability to adjust focus. Employee is required to regularly talk and hear.

TOTAL COMPENSATION:

The base pay range below reflects the potential hourly compensation for this position. Compensation will vary based on factors including experience. Other benefits include weekly transportation benefit, competitive Paid Time Off package, medical insurance, comprehensive ancillary benefit offerings, 401K plan with employer match, and more. 

Additional information:

Please note that offer of employment is contingent upon successful completion of background check, pre-employment physical, and drug screen as they align with New York State requirements.

Additionally, this is an ITAR compliance related position. The offer is contingent upon proof of US Person status (US Person is defined under ITAR as a natural person who is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3)) or an export control license for non-US Persons.