At Truepill, we are building the future of healthcare. Through our digital health platform, we empower our partners to deliver world-class patient experiences. With nearly five million prescriptions shipped, we’ve been included on Forbes’ “Next Billion-Dollar Startup” list and are proud to work with many of the world’s largest healthcare organizations. We never settle for how it’s done today. We invent how it will be done tomorrow.
None of this is possible without the right team driving us forward. We are committed to creating an environment focused on racial and gender equality, inclusion, empowerment, and respect. We believe that when our teams feel supported and inspired, they turn that creativity into innovation. The type of innovation that benefits all of our people, our partners, and our patients.
We encourage our team members to expand their horizons and bring their passion and curiosity to work, every day. Come join us. Let’s build something great together.
In this role, you will have end-to-end accountability for the medical device manufacturing and process engineering of our diagnostics products. You will be responsible for establishing, managing, and optimizing our quality and manufacturing process in compliance with FDA and other regulatory requirements. You will work collaboratively across the company to achieve the goals of the diagnostics business. You will report to the VP & GM, Diagnostics.
What You'll Be Doing:
- Develop SOPs, manufacturing instructions, router packets, process validations, training materials, supplier and component controls, etc in compliance with the quality system and other regulatory requirements
- Ensure that processes and methods are robust, scalable, well-characterized, user-friendly, economical, and in compliance with established quality procedures.
- Develop and introduce best-in-class operations excellence initiatives to improve quality, productivity, and performance.
- Meet SLA obligations through effective capacity management, production planning/scheduling, and material management
- Define, establish, monitor, and report key performance and quality metrics to meet manufacturing objectives.
- Ensure the KPIs and key goals are achieved, and that manufacturing capacity meets the established plan.
- Collaborates with and coordinates other functions’ activities in order to deliver goals in compliance with the quality system (HR, Finance, Fulfillment, Supply Chain, Compliance, BD)
We're Looking For Someone With:
- 7+ years of experience in the medical device industry
- Experience in medical manufacturing under FDA/GMP conditions in a medical device manufacturing environment, preferably experience in high volume contract manufacturing.
- Strong foundation with high-frequency new product introduction (NPI) through high volume scale-up
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Experience with managing technicians.
- Proven ability and system to manage multiple priorities in a fast-paced environment
- Experience with FDA 21CFR820 and ideally ISO 13485
Truepill is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
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