Vacancy expired!
- Participate in or lead teams in supporting quality disciplines, decisions, and practices,
- Lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP)
- Design change projects, accountable for generation of PDP design verification test plans/reports for product/system requirements, lead or support
- Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments, lead identification of essential outputs and generate
- Essential Output reports, accountable for completion of labeling verification activities and labeling verification reports
- Work with design engineering in the completion of customer/system/product requirements,
- Work with design engineering in the completion of product verification and validation,
- Endure DHF content completion, integrity and regulatory & standards compliance,
- Collaboratively communication resolving gaps, complete document change request reviews in a timely and objective manner,
- identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements,
- Assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements,
- Assist in the development and execution of streamlined business systems which
- Effectively identify and resolve quality issues, apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues,
- Support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements,
- additional duties may be identified by functional management based on the current project/business objectives.
Vacancy expired!