ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That’s why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby—no matter how they do it.
When we launched our Whole Nutrition Infant Formula in March 2022, we were the first new U.S infant formula manufacturer in 15 years. Since then, we’ve been leading the way in a lot of ways.
We’re…
- The only U.S.-made infant formula to use organic, grass-fed whole milk
- The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk—alpha-lac and lactoferrin—to our ingredients list
- The first infant formula company to receive Clean Label Project’s Purity Award (and we test for 700 contaminants vs the required 400)
- We ran the largest clinical trial by a new infant formula brand in 25 years—clinically proving our benefits vs a leading infant formula like:
- Less spit up
- Softer poops
- Easier digestion
- More efficient weight gain
- Enhanced nutrient absorption
- Longer stretches between nighttime feeds*
With >$250M in funding, we’re shifting the industry forward—and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of >275 people that stretches across the country.
We're proud to offer competitive, family-first benefits, including but not limited to:
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Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family.
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Flexible paid time off: plus 12+ company holidays, and 2 floating holidays to use at your discretion!
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16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time.
- Up to 6% 401(k) Match to help you plan for your future.
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Company equity for every employee: because when we succeed, we succeed together!
Visit our site to learn more, and check out some recent press on ByHeart:
*based on data from infants at approximately 4 months of age
Role Description
The Quality Customer Service Manager is responsible for effectively managing all product complaints by ensuring investigations are conducted thoroughly and within required timelines and to regulatory requirements. This position works closely with internal and external Customer Service partners to maintain and improve the company’s relationship with customers and consumers while meeting quality and regulatory compliance. This function provides leadership and direction in accordance with departmental and company goals and priorities to drive improvement.
Reports To: Senior Manager, Quality Compliance
Location: Remote
Role Responsibilities
- Accountable for managing and overseeing the Complaint Program throughout the ByHeart supply chain including the investigation process, root cause analysis through to the implementation of preventative measures as a result of production, complaints, and supplier events.
- Ensures investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the corrective & preventive action.
- Responsible for managing all CAPA effectiveness checks associated with the Complaint Program.
- Responsible for tracking and trending product complaints and adverse events, assessing for reportability, and escalation to Management as needed.
- Develops and maintains complaint procedures.
- Responsible for Quality programs:
- Complaint Management (Trackwise System management/configuration, Triage, investigations, CAPA, Trending, Escalation, Customer Responses),
- Quality Customer Service for external (Retail, DTC, Suppliers) and internal (Parent Experience, Pharmacovigilance, Branding, Legal, Medical) partners as the liaison for quality-related requests, certifications and customer communications.
- Establish implementation plan for strategic objectives to enhance Complaint systems and compliance across ByHeart sites, incorporating integration of best practices.
- Collaborate with other functional area goals and priorities by soliciting information from those functional groups for continuous improvement and innovation.
- Make decisions based upon assessment of information from many sources including customers, manufacturing processes, QC testing, and other available information.
- Provide strategic technical guidance and management support for quality functions minimizing workload, optimizing resources, streamlining existing systems, and contributing to continuous improvement opportunities.
Skills & Qualifications
- Bachelor Degree
- 10 years of work and school experience
- Minimum of 5 years in regulatory industry
- Process and system management experience
- Detailed knowledge of Quality Management Systems and processes required
- Knowledge of FDA requirements and understand how to develop applicable SOPs that are compliant to applicable regulations
- Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
- Provides well written investigation and technical summaries (meets defined quality standards) for Senior Management.
Additionally, you will be eligible for a discretionary performance based annual cash bonus and to participate in our company’s equity program, plus our robust medical, dental, vision, retirement, and other benefits.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
