Manufacturing Quality Assurance Manager

Job Description

The Manufacturing Quality Assurance (MQA) Manager is responsible for leading quality assurance activities at the Cedar Creek site. This role ensures products are manufactured and released in compliance with quality standards, regulatory requirements, and company policies.

The MQA Manager leads a team of quality professionals, drives continuous improvement, supports regulatory inspections and audits, and partners with cross-functional teams to ensure product quality and compliance. This position serves as a key member of the site Quality Leadership Team and acts as a delegate for the Site Quality Head when needed.

Key Responsibilities

Team Leadership

• Lead, coach, and develop a team of Manufacturing Quality Assurance professionals.
• Set priorities, manage workloads, and ensure effective team performance.
• Support recruiting, onboarding, employee development, and succession planning.
• Foster a culture of quality, accountability, collaboration, and continuous improvement.

Quality Systems & Compliance

• Ensure compliance with FDA, ISO, cGMP, and company quality requirements.
• Maintain inspection readiness and support internal, customer, and regulatory audits.
• Provide oversight of quality system processes including: Deviations and investigations Nonconformances Corrective and Preventive Actions (CAPA) Change controls Rework activities
• Monitor quality metrics, identify risks, and drive timely resolution of issues.

Manufacturing & Product Quality

• Provide quality oversight for manufacturing operations.
• Ensure products are manufactured, tested, documented, released, and distributed according to approved procedures and regulatory requirements.
• Oversee batch record review, product disposition, material management, and release activities.
• Make independent quality decisions and escalate potential quality or compliance risks when necessary.
• Partner with Manufacturing, Engineering, Quality Control, Supply Chain, Validation, Regulatory Affairs, and other functional teams.

Validation & Continuous Improvement

• Oversee qualification and validation activities for equipment, processes, systems, and methods.
• Ensure effective root cause investigations and implementation of corrective actions.
• Analyze quality data and trends to identify opportunities for improvement.
• Lead quality improvement initiatives that strengthen compliance, efficiency, and product quality.
• Promote risk-based decision-making and Lean/Six Sigma methodologies.

Communication & Governance

• Track and communicate quality performance metrics, trends, and risks.
• Contribute to Quality Management Reviews and site leadership meetings.
• Ensure accurate and timely reporting of significant quality events.
• Represent Manufacturing Quality Assurance during audits, inspections, and cross-functional meetings.

Qualifications

Minimum Qualifications

Education

• Bachelor's degree in Science, Engineering, Quality, or a related technical field required.
• Advanced degree and/or professional quality certifications preferred.

Experience

• 8+ years of quality experience in a regulated manufacturing environment (medical device, pharmaceutical, biotechnology, or similar industry).
• 3+ years of people leadership experience, including coaching, performance management, and team development.
• Experience with Quality Management Systems (QMS).
• Experience supporting audits, inspections, and interactions with regulatory agencies or external auditors.
• Strong knowledge of FDA regulations, ISO 13485, and cGMP requirements.
• Experience using quality metrics, risk management, and data analysis to improve performance.
• Medical device or diagnostics manufacturing experience preferred.
• Ability to travel occasionally as business needs require.

Preferred Skills

• Strong leadership, coaching, and team development capabilities.
• Excellent problem-solving, root cause analysis, and risk assessment skills.
• Sound judgment and the ability to make independent quality decisions.
• Strong analytical and data-driven decision-making skills.
• Effective communication and stakeholder management across all organizational levels.
• Ability to manage multiple priorities in a fast-paced, regulated environment.
• Continuous improvement mindset with experience driving sustainable quality solutions.

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least October 6, 2026 or until the job is no longer posted.

The full-time equivalent pay range for this position is $127,680.00 - $199,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:

Occasional

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory