"Alerted.org

Job Description

Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development. Responsible for design control and risk management of next-generation medical devices. Uses clinical knowledge to influence how devices they are working on are tested and designed. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects. Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards. Demonstrates good working knowledge in pharmaceutics or combination regulatory requirements, 21 CFR 211 and ICH Quality Guidelines. Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team. Promotes and influences compliance to quality, business and health & safety systems and market/legal regulations. Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines). Keeps up to date on all ISO/EN/FDA/MDR and other Product Development related regulatory requirements and relay this information to the Product Development group

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

5 - 8 Years with BS, 3 - 6 Years with MS, 0 - 3 Years with PhD

Combination Products experience

Able to work independently and communication