Quality Engineer
Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 BSCs 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.
Employment Type
Full-time
