Quality Systems Manager

Position Summary

The Quality Systems Manager (QSM) leads the development, implementation, and continuous improvement of quality systems and processes that drive compliance, operational excellence, and business performance. This role is responsible for monitoring quality metrics, overseeing quality assurance activities, and managing quality-related costs to ensure ongoing compliance with regulatory requirements and product and facility certifications. The QSM also partners on strategic initiatives focused on reducing waste, optimizing resources, and improving process efficiency across the organization. Working cross-functionally with teams at the local, regional, and global levels, the QSM influences outcomes, supports key business objectives, and provides leadership and guidance across quality-focused initiatives.

Principal Responsibilities

•    Lead the implementation, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with regulatory, customer, and corporate requirements.
•    Provide quality systems leadership and strategic support to senior management, helping align quality objectives with broader business goals.
•    Ensure the timely deployment and adoption of corporate policies, procedures, work instructions, and quality initiatives.
Quality Systems & Compliance
•    Develop, monitor, and report key quality metrics and performance indicators to drive data-based decision-making and operational excellence.
•    Manage quality reporting processes, ensuring the accuracy, integrity, and visibility of quality data across the organization.
•    Oversee Document Control processes to ensure documentation remains compliant, current, and aligned with global quality standards.
•    Collaborate with internal and external auditors on quality system and CAPA-related activities, ensuring successful audit outcomes.
•    Direct internal and external audit programs, including planning, execution, reporting, and effective closure of audit findings.
Quality Support Functions
•    Lead quality support functions, including Calibration and Training, to ensure equipment, procedures, employee qualifications, and quality records meet applicable standards and business requirements.
•    Ensure calibration activities are performed in accordance with national and international standards.
•    Oversee training programs, SOPs, policies, and procedures to maintain compliance and organizational effectiveness.
CAPA Program Leadership
•    Serve as the site CAPA leader, overseeing the end-to-end Corrective and Preventive Action (CAPA) program and ensuring compliance with regulatory and internal quality requirements.

•    Partner with cross-functional teams to investigate quality issues, deviations, and nonconformances, driving robust root cause analysis and sustainable corrective actions.
•    Facilitate CAPA review meetings, track action plans, monitor effectiveness, and escalate critical issues as needed to ensure timely resolution.
•    Act as the CAPA subject matter expert, coaching CAPA owners, supporting compliance efforts, delivering training, and maintaining governance through regular review board meetings.
•    Ensure CAPA documentation is complete, accurate, and compliant with applicable quality and regulatory standards.
•    Continuously assess the effectiveness of the CAPA program and identify opportunities to strengthen quality systems and processes.
Continuous Improvement & Business Performance
•    Champion continuous improvement initiatives focused on waste reduction, process optimization, and overall quality system performance.
•    Lead strategic quality projects, including initiatives related to Cost of Quality, operational efficiency, and business performance improvement.
•    Analyze and interpret quality data to generate actionable insights, trend analyses, and management reports.
•    Compile, maintain, and communicate quality metrics and project outcomes to support informed decision-making and organizational goals.

Education / Experience Requirements

•    Bachelor's degree in Engineering, Life Sciences, Quality Management, Manufacturing, or a related technical discipline preferred.
•    In lieu of a degree, a minimum of 8–10 years of progressive experience in Quality Assurance, Quality Systems, or a related quality-focused function will be considered.
•    Experience in a manufacturing environment required; experience within medical device, pharmaceutical, biotechnology, diagnostics, or other regulated industries strongly preferred.
•    Demonstrated experience supporting or leading Quality Management Systems (QMS) in a regulated environment.
•    Experience managing audits, CAPA programs, document control systems, training programs, and quality compliance activities preferred.
•    Previous leadership experience, including managing teams, leading cross-functional initiatives, influencing stakeholders, and driving organizational change.
•    Proven ability to prioritize competing demands, manage multiple projects, and achieve results in a fast-paced environment.

Specialized Skills / Other Requirements

•    Strong knowledge of applicable quality and regulatory requirements, including FDA Quality System Regulations (QSR), 21 CFR requirements, cGMP, and ISO standards.
•    Working knowledge of quality system processes, including CAPA, change control, nonconformance management, document control, training, and audit management.
•    Strong analytical and problem-solving skills, including experience with Root Cause Analysis methodologies such as 5 Whys, Fishbone/Ishikawa, 6M, and Cause-and-Effect Analysis.
•    Experience with Design Controls and Risk Management methodologies preferred.
•    Knowledge of statistical analysis and process improvement techniques, including SPC, Gage R&R, and Design of Experiments (DOE), preferred.

•    Experience with electronic Quality Management Systems (eQMS), ERP systems, and business applications; SAP and Agile experience strongly preferred.
•    Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint.
•    Experience with data analysis and reporting tools such as Minitab preferred.
•    Excellent verbal, written, and interpersonal communication skills with the ability to effectively collaborate across all levels of the organization.
•    Ability to work independently, exercise sound judgment, and maintain a strong focus on quality, compliance, and continuous improvement.

The pay range for this position at commencement of employment is expected to be between $127,000 - $190,500, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

#LI-EB1

Working Conditions / Physical Demands

TRAVEL REQUIRED: 5 %

WORKING ENVIRONMENT:
☒ Office/Professional        ☒ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory