120000.00 - 140000.00 Yearly
- Focuses on the development and identification of product requirements based on internal and external client feedback.
- Focuses on the quality, design, experience and value of current products in the market as well as the next product in development.
- Applies domain experience in a creative and innovative manner in order to ensure that the company is building world class products in-line with client, market and government regulations
- Leads all phases of a product program, from concept through planning, development, go-to-market, launch and post-launch
- Coordinates with program team members following a structured process and delivering artifacts that must be completed throughout the phases of software development lifecycle
- Responsible for managing feature enhancements, evaluating the impact of quality on a product and ensure a high quality and satisfying experience for our clients
- Develop key product themes that are to act as the foundational messaging for marketing and other corporate constituents
- Perform market studies in order to ascertain and validate the approach of the product/process
- Leads Product Design Workshops and other forums to solicit feedback, directional guidance, and validation of their product direction using a variety of tools and approaches
- Responsible for tracking and reporting on updates and proposes updates to regulations which affect life science and medical device companies
- BS degree in a relevant program of study
- Prior experience working in Pharmaceutical, Biotech, or Medical Device Quality Assurance, with at least 5 years of experience in pre-commercial quality control or assurance (for example: analytical development and support, product development/ technical services).
- Strong understanding and experience applying GxP quality processes; experience with quality process optimization and “fit for purpose” quality processes across the product lifecycle; experience with KPI, metrics, and data reporting and analytics expectations within the quality space.
- Strong understanding of current Life Sciences industry regulatory agencies, regulations, standards, guidelines, etc.
- Knowledgeable about pain points and inefficiencies in current processes and systems.
- Should be willing to travel <25% for customer meetings and project engagements