FDA Compliance

Quality Assurance Regional Manager – Albert Lea, MN

Quality Assurance Regional Manager

📍 Location: Albert Lea, Minnesota (Oversight of Multiple Manufacturing Sites)
💼 Employment Type: Full-Time
💰 Base Salary: $130,000 – $145,000
🚚 Relocation Assistance: Available for Ideal Candidates
✈️ Travel: Frequent Regional Travel Required
🚫 Visa Sponsorship: Not Available

Overview

A growing manufacturer in the food and nutrition sector is seeking a Quality Assurance Regional Manager to lead quality and food safety operations across multiple production facilities in Minnesota.

This leadership role is responsible for driving food safety, regulatory compliance, quality system effectiveness, continuous improvement, and team development while partnering closely with Operations, Production, R&D, and Commercial teams.

The successful candidate will be a strong people leader with deep expertise in FDA-regulated manufacturing environments and a proven ability to influence cross-functional teams.

Key Responsibilities

Quality & Food Safety Leadership

  • Lead quality assurance programs across multiple manufacturing sites.

  • Ensure compliance with FDA, HACCP, SQF, customer, and internal quality standards.

  • Drive continuous improvement initiatives focused on food safety, quality, and operational excellence.

  • Oversee internal audit programs, CAPA processes, and compliance activities.

  • Lead root cause investigations and implement sustainable corrective actions.

Team Leadership

  • Develop, coach, and mentor regional quality teams.

  • Establish and communicate performance goals using SMART objectives.

  • Build a culture of accountability, food safety, and continuous improvement.

  • Deliver food safety and quality training programs.

Cross-Functional Collaboration

  • Partner with Production, R&D, Commercial, and Operations teams to support product launches and process improvements.

  • Support commercialization activities, change control processes, and new product introductions.

  • Provide quality leadership during customer visits, regulatory inspections, and external audits.

Systems & Compliance

  • Ensure effective implementation of food safety and quality management systems.

  • Monitor and improve key metrics including:

    • First Pass Quality

    • Customer Complaints

    • CAPA Effectiveness

    • Inventory Health

    • Compliance Performance

    • Environmental & Sanitation Programs

  • Apply SPC and data-driven methodologies to improve process performance.

Required Qualifications

  • Bachelor's Degree in Science or a related field.

  • 10+ years of Quality Assurance experience within:

    • Food Manufacturing

    • Beverage Manufacturing

    • Dietary Supplements

    • Pharmaceutical or Medical Device Manufacturing

  • Management experience leading quality teams.

  • Strong knowledge of:

    • FDA Regulations

    • HACCP

    • SQF

    • Food Safety Programs

  • U.S. Citizen or Permanent Resident.

Preferred Experience

  • Multi-site quality leadership experience.

  • Career progression across multiple functions including:

    • Production

    • R&D

    • Quality

  • PCQI certification.

  • Strong experience working with cross-functional teams.

  • Statistical Process Control (SPC) expertise.

  • Project management and continuous improvement experience.

Key Skills

✔ Quality Assurance Leadership
✔ FDA Compliance
✔ HACCP & SQF Programs
✔ Food Safety Systems
✔ CAPA Management
✔ Root Cause Analysis
✔ Internal Auditing
✔ SPC & Data Analysis
✔ Team Development
✔ Cross-Functional Leadership

Ideal Candidate

The ideal candidate has a strong quality leadership background within food or beverage manufacturing and has progressed through multiple operational disciplines such as Production, R&D, and Quality.

They will bring:

  • Multi-site quality management experience.

  • Strong food safety and regulatory expertise.

  • Proven success leading cross-functional initiatives.

  • Excellent leadership, coaching, and communication skills.

  • A track record of driving continuous improvement and quality culture transformation.

Screening Questions

  1. Do you have experience in the food and beverage manufacturing industry?

  2. Do you have hands-on experience with HACCP, SQF, and food safety systems?

  3. Are you a U.S. Citizen or Permanent Resident?

  4. Have you successfully partnered with cross-functional teams across operations, R&D, and quality?

  5. Have you held roles in multiple functions such as Production, R&D, and Quality during your career?

Candidate Snapshot

Requirement

Details

Experience

10+ Years

Seniority

Director Level

Education

Bachelor's Degree

Industry

Food & Beverage Manufacturing

Management Experience

Required

Travel

Frequent

Multi-Site Oversight

Preferred

Relocation

Available

Why Consider This Opportunity?

  • Lead quality operations across multiple manufacturing facilities.

  • High visibility role with direct impact on food safety and operational excellence.

  • Strong career growth opportunities within a growing organization.

  • Collaborative environment with significant cross-functional leadership exposure.

  • Opportunity to shape quality strategy and drive continuous improvement initiatives across multiple sites.

 

Manufacturing Operations Manager | $106K–$150K | Consumer Products | Sanford, ME

Manufacturing Operations Manager

Location: Sanford, Maine
Job ID: 167229
Employment Type: Full-Time

💵 Compensation:

  • Base Salary: $106,000 – $150,000/year

  • Bonus Eligible: No

  • Commission: No

  • Overtime Eligible: No

🎁 Benefits:

  • Full benefits package (medical, dental, vision, 401k, etc.)

  • Relocation assistance available for the ideal candidate

  • Paid time off (PTO) and holidays

  • Career development and advancement support

  • Opportunities for continuous improvement training (Lean, Six Sigma, etc.)

Lead. Innovate. Transform.

Are you a manufacturing leader ready to take the next step in your career? This exciting opportunity offers the chance to drive operational excellence, lead high-performing teams, and influence end-to-end production strategies at a dynamic consumer products facility in Sanford, Maine.

You’ll oversee production, warehouse, and finishing operations while fostering a safety-first, quality-driven, and continuous improvement culture. Bring your passion for innovation, people leadership, and efficiency—and make a measurable impact on global supply chain performance.

What You’ll Be Responsible For

🔧 Operations Leadership

  • Oversee daily operations across production, making, finishing, and warehouse areas

  • Lead supervisory teams and technicians to meet KPIs around quality, safety, and efficiency

  • Drive a culture of accountability, performance, and collaboration

  • Partner cross-functionally with Engineering, Maintenance, Quality, and EH&S to maximize productivity

  • Champion Factory Performance & Reliability (FP&R) standards including People Capability, Visual Workplace, and Continuous Improvement

  • Act as a visible, hands-on leader during audits, SOP reviews, and daily operations

  • Build contingency plans to ensure business continuity during disruptions

💰 Financial Oversight

  • Co-own plant financial performance with site leadership

  • Drive savings initiatives through labor cost optimization and FTG (Fund-the-Growth) programs

  • Analyze variances in materials, labor, and output to improve financial forecasting

  • Optimize inventory, capital expenditures, and operating expenses to improve cash flow

  • Monitor and revise site KPIs to align with evolving business goals

👥 People & Culture

  • Execute labor strategies that promote employee relations, retention, and engagement

  • Build and mentor a high-performing workforce, empowering both salaried and hourly teams

  • Develop internal talent pipelines while fostering a culture of recognition and inclusion

✅ Quality, Compliance & Process Excellence

  • Ensure all production activities align with GMP, FDA, and safety standards

  • Own decisions regarding out-of-spec raw materials, WIP, and finished goods

  • Guarantee team proficiency with SOPs for lot tracking, release procedures, code dating, and traceability

  • Lead implementation of corrective/preventive actions for non-conformances

  • Ensure validated cleaning, sanitization, and changeover procedures are followed

  • Facilitate successful technology transfers for new products and processes

⚙️ Process & Equipment Optimization

  • Set annual site goals for process capability; monitor and report on monthly progress

  • Ensure process control tolerances, calibration routines, and SOP accuracy

  • Identify and resolve equipment constraints in partnership with technical teams

  • Oversee preventive maintenance and ensure team training on cleaning and batch procedures

What You Bring

  • Bachelor’s Degree in Engineering or related discipline (required)

  • 8+ years of progressive leadership in manufacturing operations

  • Strong background in GMP, FDA/regulated environments, and ISO/OSHA standards

  • Solid understanding of Quality systems and manufacturing audits

  • Advanced proficiency with digital tools (e.g., Google Suite, Data Studio)

  • Experience leading cross-functional teams and navigating matrixed environments

Preferred Qualifications

  • SAP, WMS, and plant floor systems experience

  • Certified or experienced in Lean Six Sigma or continuous improvement methodology

  • Proven ability to manage ambiguity and multiple initiatives simultaneously

  • Strong communicator with excellent coaching and feedback capabilities

  • Project management skills with experience leading complex initiatives

Additional Details

  • Seniority Level: Mid-Senior

  • Management Experience: Not required, but leadership experience essential

  • Travel: Occasional

  • Visa Sponsorship: Not available

  • Security Clearance: Not required

  • Relocation Assistance: Yes, for the ideal candidate

Take Charge of Change

This role is built for a strategic, hands-on leader who thrives in a fast-paced, quality-first environment. If you're ready to elevate your impact, drive performance, and shape the future of manufacturing—this is your opportunity.

 

Senior Supply Chain Manager | Medical Devices | $150K–$160K | Sumter, SC

Job Title: Senior Supply Chain Manager
Location: Sumter, South Carolina (Onsite – Manufacturing Facility)
Industry: Medical Technology / Medical Devices
Employment Type: Full-Time
Seniority Level: Mid-Senior
Travel: Up to 25%
Visa Sponsorship: Not Available
Security Clearance: Not Required
Relocation Assistance: Possible for the right candidate
Compensation: $150,000–$160,000 base salary + full benefits
Bonus Eligible: No
Interview Travel Reimbursed: Yes

Overview:

This role is a strategic and hands-on leadership opportunity within a leading global medical technology manufacturer. The Senior Supply Chain Manager will lead the end-to-end supply chain operations for a high-volume manufacturing plant, overseeing planning, purchasing, sterilization, product flow, shipping, and master data governance. This individual will play a critical role in ensuring supply continuity, operational efficiency, inventory optimization, and cross-functional collaboration with corporate, regional, and site-based stakeholders.

Key Responsibilities:

Purchasing & Supplier Management

  • Lead procurement of raw materials, components, MRO supplies, and capital equipment.

  • Direct issuance of purchase orders and lead resolution of non-conforming materials with supplier quality teams.

  • Collaborate with One Company Procurement (OCP) for corporate sourcing compliance and improvements.

Planning & Scheduling

  • Align with global supply chain teams to balance plant efficiency with customer demand.

  • Evaluate master production schedules and global demand for molded components.

  • Drive production plan adjustments and support mitigation strategies for material shortages.

Master Data Management

  • Oversee materials control documentation, ISO/QSR/SOX compliance, and ERP data governance.

  • Lead process improvement initiatives in SAP and Apriso systems.

Sterilization Operations

  • Oversee the operation and optimization of the on-site Gamma sterilizer – the plant’s bottleneck process.

  • Liaise with microbiology, corporate sterilization, and assurance teams for SOP alignment and continuous improvement.

Shipping & Logistics

  • Ensure talent and processes are in place to support outbound product flow to distribution centers and partner plants.

Leadership of Supply Chain Teams

  • Directly manage 3 supply chain managers overseeing inbound, outbound, and planning functions.

  • Represent the plant in divisional Integrated Reconciliation Meetings and strategic planning forums.

  • Lead strategic initiatives including manufacturing transfers, make vs. buy analysis, and business continuity planning.

Reporting & Strategic Collaboration

  • Prepare and analyze capacity reports, forecast alignment, and budget planning documents.

  • Coordinate with finance, CI leadership, and marketing to ensure aligned business performance.

  • Coach and develop a team of exempt supply chain professionals in line with corporate strategies.

Minimum Qualifications:

  • Bachelor’s Degree in Business, Engineering, Supply Chain or a related field

  • 10+ years of experience in supply chain management within a manufacturing environment

  • Strong background in planning, procurement, supplier performance management, and logistics

  • Proficiency in SAP and Apriso systems

  • Demonstrated success in leading teams and managing cross-functional projects

Preferred Qualifications:

  • 15+ years of total experience in manufacturing or supply chain operations

  • Prior experience managing supply chain disruptions (e.g., raw material delays, port congestion)

  • Background in strategic supplier negotiations, cost reduction, and demand forecasting

  • Familiarity with ISO, QSR, and SOX compliance requirements

  • Continuous Improvement (CI) and transformation experience, including digitalization

Work Environment:

  • This is an on-site leadership role based in a non-smoking, regulated manufacturing environment.

  • Steel toe, non-slip footwear is required in production areas.

  • Jewelry, false eyelashes, press-on nails, and visible dermals are prohibited in production zones for safety and compliance.

Why Join?

  • Be part of a high-performing, collaborative team that supports career growth and development

  • Play a key role in ensuring medical products reach global customers safely and efficiently

  • Join a company with a strong reputation for ethical operations, innovation, and global impact

  • Contribute to critical healthcare solutions and operational excellence at a global scale