Manufacturing Quality Assurance Manager

Location: Cedar Creek

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.

Experience8+ 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 13, 2026 or until the job is no longer posted.

The full-time equivalent pay range for this position is $ - $/yr plus eligibility for bonus, stock and benefits. Our pay…