Director of Quality & Regulatory
Direct Hire – Minneapolis, MN
Welly is a rapidly growing, early commercialization, Class I medical device and OTC pharmaceutical company.
Welly is for everyone that was afraid to fall down, fail, get bumped, get scratched and did it anyway. Welly is for the wellness in all of us, however that looks, and for being prepared for whatever comes our way. We wear our bandages like badges of honor for a life fully lived.
We’re a group of adventurists and neat freaks. Dreamers and doers. Dads, moms, and dog moms. Gen Z, Millennials and eh…older than millennials. Horseback riders, runners, first timers and old pros. We banded together and took a giant leap to make a product for the bleeders, the believers, the give it a try-ers.
Welly has already been buzzed about in national media and by influencers for disrupting a rather beige category. We have 25 products at all Target stores and we are on the path for huge growth in April 2020. We need the A-team to help us on our path.
Oh yes, we’re hatched in Minnesota with partners all over the world. Our HQ is in downtown Minneapolis, overlooking all the adventure Minnesota has to offer.
As the Director of Quality and Regulatory, your mission will be to ensure our high standards of quality across all our portfolio of products, including Class I medical devices. While at Welly we all own quality – you will lead product quality, supplier quality and all regulatory efforts for the brand.
Product & Supplier Quality
- Develop and implement a quality strategy to drive organizational success
- Develop and maintain a quality system
- Establish quality SOPs across all partners from raw materials to finished products
- Assist in packaging review for quality requirements
- Complete WERCS registrations and flammability ownership
- Track and report product complaints, manage feedback and follow-up to drive quick resolution
- Lead quality management reviews
- Lead all aspects of supplier partner quality including audits, review of each partner’s quality control processes and procedures
- Lead root cause analysis and ensure resolutions are implemented and followed for quality issues with all supplier partners
- Catalog supplier COAs, efficacy certifications and manage product release timing for quarantine or production hold
- Ensure quality agreements are in place and maintained for all suppliers
- Provide organizational Regulatory Leadership
- Complete and oversee product registrations to ensure clearance to distribute products
- Understand existing FDA regulations and interpret new regulations and their impact on Welly
- Provide broader organizational training (Quality, Safety and Regulatory)
- Lead consumer feedback council
- Assist in leading Welly through certification process for becoming a B-Corp for social and environmental performance
Your Life Welly Lived
- You are a natural collaborator and problem solver with a breath of experience across the Quality function
- You understand how to infuse quality into the DNA of an organization as a leader but also enjoy hands on work
- You are proactive, highly organized, self-driven and expect the best from yourself – you genuinely see the cup half full, even under pressure
- You like to build from the ground up and you want to work as an integral part of a team that makes great things happen
Capabilities + Skills Required
- 10+ years of experience in quality and regulatory in retail healthcare
- 5+ years of medical device and/or pharmaceutical experience (OTC experience preferred)
- Strong experience in developing and implementing quality processes and procedures
- Deep knowledge of FDA regulations in the healthcare space
- Ability to lead multiple projects at a time from concept to completion
- Hard-working, collaborative, and passionate
- Proven track record of partnering across functions and with supplier partners
- Experience working with the FDA
- Natural problem solver with an open mind
- Detailed oriented with strong analytical skills
- Thrives in a complex and changing environment
- Enjoys the work, the company and the team
No recruiters please.