Our client, a medical device company in Tipperary are currently looking to recruit a Senior Quality System Engineer for their site.
Demonstrates a primary commitment to patient safety and product quality. Understands and complies with all the regulations governing the quality systems. Establish and maintain effective quality system structures to ensure consistent implementation of quality systems. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance and standards. Provide support to customer as required helping to ensure delivery of highest quality product.
- Will act as an expert resource in external regulations and standards requirement knowledge for cross functional teams. Is viewed as a leader in the areas of quality systems and ISO/MDD standards within one's own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis.
- Implementation of internal requirements and external laws, regulations, guidance's and standards as applicable to the quality systems.
- Champions continuous improvement and innovation from a quality system perspective.
- Lead and support site External Inspections.
- Identify areas of potential noncompliance or improvements by managing and conducting internal audits to schedule
- Educate functional areas on quality system requirements.
- Participate cross functionally and across business units to standardize the policies and procedures.
- Collect and analyze business/quality system process data from different parts of the company.
- Support the site corrective and preventive actions process.
- May on occasion be required to travel in order provide support the business or other sites in this area of responsibility.
- Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives.
Quality System Requirements:
- 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.
- Knowledge - A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field. Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways. General knowledge of other related disciplines, business unit function and cross group dependencies/relationships.
- Problem Solving - Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.
- Planning and Organisation - Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.
- Discretion / Latitude; Supervision received; Decision making - Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions. Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures.
- Business Relationships and project management - Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Will interact with External Parties. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
- Impact - Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
- Liaison - Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.
Level 8 quality qualification and 3/5 years relevant work experience
For further information on this Senior Quality System Engineer role in Tipperary please contact Nicola O'Connell on 091730022 / email@example.com
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