Quality Systems and Risk Management Manager

Keller Executive Search; City of Rochester (NY); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Relocation assistance

Sign-on bonus

On-site role with limited remote work

Limited travel

Job summary

Keller Executive Search is partnering with a leading manufacturing organization to appoint an experienced Quality Systems and Risk Management Manager. This role focuses on developing and maintaining a robust quality management system, while advancing risk identification, mitigation, and control across the product lifecycle.

You will drive audit readiness, collaborate cross-functionally, and mentor the quality team to embed a culture of continuous improvement in a regulated manufacturing

Qualifications

• Bachelor’s degree in engineering, quality, life sciences, or a related technical field.
• 5+ years of experience in quality systems, quality assurance, or quality management within a manufacturing or regulated environment.
• Working knowledge of ISO 13485, FDA Quality System requirements, and ISO 14971 risk management principles.
• Practical knowledge of risk management methodologies and CAPA processes.
• Experience planning and conducting internal and external audits.
• Ability to work on-site as the primary work location.

Responsibilities

• Own, maintain, and continuously improve the quality management system to ensure ongoing compliance with applicable standards and regulations.
• Lead the organization’s risk management program, including risk assessments, mitigation planning, and CAPA.
• Plan, conduct, and coordinate internal and external audits, and manage responses to regulatory and customer audits.
• Develop, review, and control quality documentation, procedures, and records to support audit readiness.
• Manage supplier and contract-manufacturer quality, including qualification, monitoring, and periodic on-site assessments.
• Analyze quality data and trends to drive root-cause investigations and measurable improvements.
• Partner with operations, engineering, and supply chain to embed quality and risk controls across the product lifecycle.
• Lead, mentor, and develop quality staff and champion a culture of continuous improvement.
• Prepare and present quality and risk metrics and reports to senior management.

Skills

Regulatory compliance

Risk management

Audits

Data analysis

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in engineering, quality, life sciences, or related technical field

Tools

QMS software

Job description

Keller Executive Search is partnering with a leading manufacturing organization to appoint an experienced Quality Systems and Risk Management Manager. This is a pivotal role for a quality professional who thrives at the intersection of systems governance, regulatory compliance, and proactive risk management, and who wants to make a measurable impact on product quality and operational excellence.

Reporting into senior leadership, you will own the design, maintenance, and continuous improvement of the quality management system while leading a structured approach to risk identification, mitigation, and control across the product lifecycle. You will work cross-functionally with operations, engineering, supply chain, and external partners to ensure that quality standards, regulatory requirements, and customer expectations are consistently met.

This is an excellent opportunity for someone ready to shape quality strategy, strengthen audit readiness, and embed a culture of continuous improvement. Our client values rigor, collaboration, and forward-thinking problem solving, and offers a stable, growth-oriented environment where quality leadership is genuinely valued.

Key Responsibilities

• Own, maintain, and continuously improve the quality management system to ensure ongoing compliance with applicable standards and regulations
• Lead the organization’s risk management program, including risk assessments, mitigation planning, and corrective and preventive actions (CAPA)
• Plan, conduct, and coordinate internal and external audits, and manage responses to regulatory and customer audits
• Develop, review, and control quality documentation, procedures, and records to support audit readiness
• Manage supplier and contract-manufacturer quality, including qualification, monitoring, and periodic on-site assessments
• Analyze quality data and trends to drive root-cause investigations and measurable improvements
• Partner with operations, engineering, and supply chain to embed quality and risk controls across the product lifecycle
• Lead, mentor, and develop quality staff and champion a culture of continuous improvement
• Prepare and present quality and risk metrics and reports to senior management

Additional Information

• Location: United States; specific site details shared later in the process.
• Working pattern: primarily on-site with occasional remote flexibility based on business needs.

Essential

• Bachelor’s degree in engineering, quality, life sciences, or a related technical field
• 5+ years of experience in quality systems, quality assurance, or quality management within a manufacturing or regulated environment
• Working knowledge of ISO 13485, FDA Quality System requirements, and ISO 14971 risk management principles
• Practical knowledge of risk management methodologies and CAPA processes
• Experience planning and conducting internal and external audits
• Strong analytical, documentation, and problem-solving skills
• Ability to work on-site as the primary work location

Preferred

• Professional certification such as CQE, CQM, CQA, Six Sigma, or Lead Auditor
• Experience with regulated or highly controlled manufacturing environments
• Prior people-management or team leadership experience
• Experience managing supplier or contract-manufacturer quality
• Experience with electronic quality management systems

Ideal Candidate Profile

You are a detail-driven yet strategically minded quality leader who balances compliance discipline with practical, continuous-improvement thinking. You communicate clearly across functions, influence without authority, and stay calm and organized during audits. You take ownership of quality outcomes and enjoy building robust systems that scale.

• Relocation support is available for candidates who are not local; this can be structured as coverage of relocation costs or as a flat sign-on bonus to help the successful candidate make the move.
• This is primarily an on-site role with limited flexibility for occasional remote work based on business needs and responsibilities.
• Only limited travel is expected, typically a few trips per year for supplier or contract-manufacturer visits, audits, or industry events; site visits can be covered by other team members where travel is not feasible.

Equal Employment Opportunity and Non-Discrimination Policy

Equal Employment Opportunity Statement: Both Keller Executive Search and our clients are Equal Opportunity Employers. For all positions, whether with Keller Executive Search or our clients, qualified applicants will receive consideration for employment without regard to race, skin color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran status, disability, genetic information, or any other legally protected status.

Commitment to Diversity: Keller Executive Search and its clients are committed to fostering a diverse and inclusive work environment where all individuals are valued and respected.

Reasonable Accommodations: Both Keller Executive Search and our clients are committed to providing reasonable accommodations to individuals with disabilities and pregnant individuals. We engage in an interactive process to determine effective, reasonable accommodations.

Compensation Information: For client positions, compensation information is available in the job post. If not provided, it will be shared during the interview process in accordance with applicable laws. When required by law, salary ranges will be included in job postings. Actual salary may depend on skills, experience, and comparison to current employees in similar roles. Salary ranges may vary based on role and location.

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• Colorado, Nevada, New York City, California, and Washington Residents: Compensation information is available in the job post or will be provided during the interview process if not initially available.
• Both Keller Executive Search and our clients are committed to pay equity and conduct periodic pay equity analyses in accordance with applicable laws.

State-Specific Information:

• Rhode Island: We do not request or require salary history from applicants.
• Connecticut: We provide wage range information upon request or before discussing compensation.
• New Jersey: We do not inquire about salary history unless voluntarily disclosed.

Veteran Status: Both Keller Executive Search and our clients provide equal employment opportunities to veterans and comply with applicable state laws regarding veteran preference in employment. If you are a veteran, please inform us during the application process.

Use of Artificial Intelligence in Recruitment

Keller Executive Search and our clients may use artificial intelligence (AI) tools to assist in the recruitment and candidate evaluation process. These tools are used exclusively to support human decision-making by helping to review and assess candidate qualifications and materials. AI is never used to automatically reject, disqualify, or make final hiring decisions about candidates. All AI-assisted evaluations are reviewed by experienced recruitment professionals, and all hiring decisions are made by qualified human recruiters. Our use of AI is designed to enhance fairness, consistency, and efficiency while maintaining our commitment to equal employment opportunity and non-discrimination principles.

Genetic Information: In accordance with federal and state laws, both Keller Executive Search and our clients do not discriminate based on genetic information. We do not request or require genetic information from applicants or employees, except as permitted by law.

Local Laws: Both Keller Executive Search and our clients comply with all applicable local laws and ordinances regarding employment practices in the areas where we operate.

Note: This job posting may be for a position with Keller Executive Search or one of our clients. The specific employer will be identified during the application and interview process. Employment laws and requirements may vary depending on the employer and location.