Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
- Develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. 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.
- Functional Engineering Roles include Design Assurance.
Responsibilities:
- Responsible for design control and risk management of next-generation medical devices.
- Use clinical knowledge to influence how devices they are working on are tested and designed.
- Apply 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 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 with BSC's 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.
Quality Systems Duties and Responsibilities:
- In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
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.