Quality Systems Engineer II
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet 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, operational, or system/services support.
- Demonstrate a primary commitment to patient safety and product quality.
- Ensures all direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.
- Responsible for the implementation, co-ordination and continuous review of the CAPA, Internal and Corporate Compliance programs
- Has expertise in internal auditing techniques and is familiar with all regulatory requirements (e.g., FDA, ISO and MDD).
- Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
- Familiar with the internal auditing system.
- Understands and proactively follows through on the Environmental Management Procedures that have been identified as relevant to position.
- Acts as a leader of quality, QSR and ISO/MDD standards within one’s own group, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
In all actions, 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. For those individuals that supervise others, the following statements are applicable:
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
- HETAC Level 8 qualification in a STEM discipline
- Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required.
- Good interpersonal skills and organisational skills.
- Excellent attention to detail.
- Communicates any concerns about work process regarding environmental impact, health or safety issues to their Manager.
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