Quality Manager

Designs for Health is an industry-leading and rapidly growing manufacturer and distributor of nutritional supplements offered primarily through health care practitioners. By providing comprehensive support through our extensive product line, ongoing clinical education, and practice development programs, Designs for Health helps practitioners realize successful health outcomes for their patients. The company has two manufacturing plants and four distribution centers in the United States, and its products are distributed in five continents.

Position Overview

This position is responsible for ensuring compliance to product (food) safety and quality elements as related to fx chocolate's manufacturing operations. This responsibility includes but is not limited to ensuring compliance to corporate quality programs, handling audits and leading/implementing sustainable improvements. This position manages, is accountable to and upholds quality in all operational processes as defined by 21 CFR 111. The person in this position expected to be a team player within corporate quality functions and an ambassador of quality for the site's management team.

Supervisory Responsibilities (indicate yes or no)

• Yes (as business needs dictate)

Essential Job Duties/Responsibilities:

• Hands-on approach to quality! (This is a small operation & the ability to establish good working relationships with the floor is essential, alongside direct performance of verification activities like ATP & Environmental Monitoring, Allergen Validations, and Ingredient, Equipment and Process validations.)
• Audits and ensures ongoing compliance of food safety and quality against 21 CFR 111/117
• Through partnering with local operations leadership, ensures floor compliance to established quality programs including:
• cGMP
• Audit (Internal, External and Regulatory)
• International Compliance Initiatives (Canada, Australia)
• Training
• Document Control
• Deviation
• Root Cause Analysis and CAPA
• Food Safety Plans
• Complaints
• Non-conformances
• Calibration
• Ensures that established weekly, monthly, quarterly and annual quality system activities are completed on schedule and any deviations are addressed in a timely manner
• Coordinates with operations site leadership to drive improvements
• Right First Time: drives prevention vs. detection of defects
• Coordinates actions to prevent the occurrences of nonconformities
• In regard to upholding quality standards, responsible for performance evaluation, coaching, counseling, and preparing corrective action for employees and liaises appropriately with HR and other support functions
• Shared responsibility with Production Manager for sanitation program which includes sanitation procedures, housekeeping, and pest control procedures that are required per 21 CFR part 111 Section 111.15

Requirements

• Bachelor degree in related field preferred but equivalent experience acceptable
• (not negotiable) Minimum 5 years experience reporting to quality in a regulated industry (manufacturing food, dietary supplements, medical devices, pharma, QTC, etc)
• Minimum 2 years of supervisory experience
• Experience with HACCP/HARPC, FSVP, NSF, GFSI, FDA, USDA Organic, SPC strongly preferred
• Equivalent combination of education and experience

Competencies

• High sense of accountability
• Self-driven
• Project Management ability
• Continuous Improvement Mindset
• Ability and desire to motivate and influence people positively
• STRONG risk assessment, organizing, planning, and problem-solving skills
• Effective interpersonal and communication skills
• Effective time management

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Occasional lifting of 0 to 25 lbs.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Reports to: Sr. Director Quality

Privacy
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Our Commitment to Diversity, Inclusion & Belonging
Designs for Health is an equal opportunity employer. We welcome diversity and are committed to creating an inclusive environment where all employees can grow and thrive. Our employees form meaningful and often life-long connections while working at Designs for Health. We are all passionate about our mission of designing a well world, together.