Quality Assurance Manager

Accrescent Group; Albert Lea (MN); On-site; USD 104,000 - 127,000; Full time

Job summary

Accrescent Group is seeking a Quality Assurance Manager to lead the site quality function in a regulated manufacturing environment. You will drive QA/QC programs, CAPA, audits, change control, and food safety compliance while partnering with Production, R&D, and Supply Chain to deliver safe, compliant products.

The role requires 5+ years in QA within FDA-regulated industries, PCQI/HACCP certification, and proven leadership to develop the site quality team and sustain continuous improvement.

Qualifications

• Experience applying QA/QC in regulated manufacturing environments.
• Familiarity with HACCP, GFSI schemes (SQF/BRC) and FDA regulations.
• Strong CAPA, root cause analysis, and internal audit capabilities.

Responsibilities

• Lead development and management of QA and QC programs.
• Oversee CAPA, complaints, audits, and change control processes.
• Ensure food safety programs including HACCP, allergen control, and sanitation.
• Drive continuous improvement and risk reduction across site operations.
• Prepare for customer visits, regulatory inspections, and external audits.

Skills

QA/QC principles

FDA Compliance

HACCP

GFSI

CAPA

Root Cause Analysis

Education

Bachelor's degree or equivalent

Tools

SPC

Job description

Job Description:

We're seeking a driven Quality Assurance Manager to lead and strengthen Quality Assurance and Quality Control functions within a regulated manufacturing environment. This role will serve as a key member of the site leadership team, responsible for ensuring product safety, quality, regulatory compliance, and customer satisfaction while developing and executing the site's strategic quality plan. The Quality Assurance Manager will oversee CAPA, customer and vendor complaints, audits, change control, food safety programs, HACCP/HARPC, sanitation, allergen control, recall readiness, environmental monitoring, and commercialization activities. The role will also lead quality improvement initiatives, develop the site quality team, collaborate with Production, R&D, Supply Chain, Commercial, and Operational Excellence teams, and drive sustainable improvements in quality performance and risk reduction.

Key Responsibilities

• Lead the development, implementation, and administration of site Quality Assurance and Quality Control programs.
• Maintain customer quality satisfaction through effective control of raw materials, in-process materials, production processes, environmental conditions, and finished products.
• Develop and execute a strategic quality plan aligned with plant and corporate objectives.
• Manage the CAPA program, including customer complaints, vendor complaints, product holds, audit nonconformances, root cause analysis, corrective actions, and effectiveness verification.
• Manage change control activities and support commercialization and new product onboarding processes.
• Develop and maintain food safety, preventive control, and prerequisite programs, including HACCP/HARPC, pest control, recall, allergen control, sanitation, and environmental monitoring.
• Ensure compliance with applicable FDA, EPA, OSHA, state, federal, and other regulatory requirements.
• Maintain compliance with third-party certification requirements such as GFSI, SQF, BRC, Kosher, Halal, and RSPO, as applicable.
• Conduct and coordinate customer, vendor, third-party, and regulatory audits and inspections.
• Prepare the site for customer visits, regulatory inspections, and external audits.
• Lead the quality team through commercial product onboarding, trial reviews, specifications, formula and label reviews, and inspection plan development.
• Establish inspection plans for raw materials, in-process materials, and finished products.
• Partner with Production, R&D, Commercial, and other functions to support successful new product, process, and equipment launches.
• Assess launch risks, quantify probability of success, and communicate risks and mitigation plans for first-time production runs.
• Drive operational excellence initiatives and integrate quality priorities into continuous improvement processes.
• Monitor key quality and operational metrics, including First Pass Quality, complaints, disposals, CAPA closure and effectiveness, inspection/compliance performance, inventory health, customer responsiveness, environmental and sanitation performance, and system effectiveness.
• Conduct root cause analysis and implement robust corrective, preventive, engineering, or system improvements.
• Lead the internal audit program and ensure corrective actions are completed effectively and on time.
• Manage departmental staffing, budget, expenses, management reviews, and capital projects.
• Develop team members through performance evaluations, training plans, coaching, and career development.
• Establish quality objectives and cascade goals using tools such as SMART goals and standardized work.
• Build strong cross-functional relationships and effectively influence site strategy and decision-making.
• Ensure timely escalation and communication of food safety, quality, and financial issues.
• Communicate professionally and effectively with internal teams, customers, inspectors, auditors, vendors, and other external stakeholders.

Knowledge, Skills & Abilities

• Strong knowledge of Quality Assurance and Quality Control principles in regulated manufacturing.
• Solid experience with FDA regulations, HACCP, SQF/GFSI, and applicable industry best practices.
• Knowledge of food safety, preventive controls, sanitation, allergen management, environmental monitoring, and regulatory compliance.
• Strong understanding of CAPA, root cause analysis, internal audits, change control, and risk management.
• Ability to apply Statistical Process Control (SPC) for process evaluation and improvement.
• Strong project management and change management capabilities.
• Ability to assess and mitigate food safety, regulatory, operational, and cost risks.
• Strong leadership, employee development, communication, and influencing skills.
• Ability to prioritize projects, meet deadlines, and manage multiple quality initiatives.
• Ability to work effectively with Production, R&D, Supply Chain, Commercial, and Operational Excellence teams.
• Strong problem-solving and decision-making capabilities.
• Ability to establish and maintain a strong site-wide quality culture.

Education

• Bachelor's degree or equivalent in a relevant field is required.

Experience & Requirements

• 5+ years of Quality Assurance experience.
• 5+ years of functional leadership experience.
• Minimum 5 years of experience in food, dietary supplement, or related regulated industries.
• Experience working in an FDA-regulated environment, preferably food or dietary supplements.
• Experience with project management and change management.
• Familiarity with FDA regulations and GFSI schemes, such as SQF or BRC.
• PCQI or HACCP certification required.
• Management and team leadership experience required.
• Experience developing and maintaining a quality culture.

Preferred Industry Experience

• Food & Beverage Manufacturing
• Dietary Supplements
• Pharmaceutical Manufacturing
• Medical Device Manufacturing
• Other FDA-regulated manufacturing environments

Working Environment & Physical Requirements

• Primarily a manufacturing/site leadership environment requiring regular collaboration with plant and cross-functional teams.
• Occasional travel may be required.
• Position requires the ability to lift up to 50 lbs.
• Ability to stand, walk, sit, reach, and perform activities associated with a manufacturing environment.

Core Skills

Quality Assurance | Quality Control | FDA Compliance | HACCP | SQF | GFSI | CAPA | Root Cause Analysis | Food Safety | SPC | Change Management | Project Management | Regulatory Compliance | Internal Audits | Quality Systems | Operational Excellence | Team Leadership | Risk Management | Continuous Improvement

Compensation:

$115,000 per year