Establish and maintain effective quality system structures to ensure consistent implementation of quality systems. Understands and complies with all the regulations governing the quality systems. Demonstrates a primary commitment to patient safety and product quality. Create processes and process improvements to ensure consistent implementation of internal requirements and external laws, regulations, guidance and standards.
- A leader and expert in the areas of quality systems, applicable medical device ISO standards, including ISO13485:2016 & ISO14971:2007 and Medical Device Regulations, including MDD93/42/EEC, MDR/2017/745, SOR/98-282, 21CFR820, & 21CFR11.
- Constantly promotes awareness of best industry practices making appropriate decisions daily. Champions continuous improvement from a quality system perspective and educates functional areas on quality system requirements.
- Implementation of internal requirements and external laws, regulations, guidance’s and standards, as applicable to the company's quality systems. Under the direction of the Senior Quality Manager, will lead and manage the alignment of the QMS to the requirements of ISO13485:2016 & 21CFR820.
- Participate cross functionally and across the business to standardize and continually improve the Quality System policies and procedures.
- Lead and support Regulatory Inspections and Notified Body audits.
- Responsible for compiling Management Review data, Quality metrics and driving continuous improvements in the quality system.
- Responsible for the Internal Audit process, CAPA & non-conformance processes and Complaints process within the organization.
- Conducting internal audits to schedule and maintaining/supporting the supplier quality management process.
- Supporting and providing input into equipment/process validations and test method validations.
- Is an effective team member and leader, fully motivated to achieve and demonstrate best practices in line with the department objectives.
Skills, Qualifications & Experience:
- Ideally will possess Degree/Post-Grad in Quality Management
- 5+ years’ experience in a medical device manufacturing environment with direct experience in a Quality Systems role and with exposure to FDA / ISO13485 / CE Registration Process.
- Experience with involvement in Regulatory submissions would be an advantage.
- Experience with involvement in design/process validations and FMEAs would be a distinct advantage.
- Lead Auditor or Internal Auditor certification an advantage.
- Excellent interpersonal and communication skills.
- Strong project management skills and attention to detail combined with proven consistent execution within quality, time and cost targets.
- Proven ability to work well as part of a team and on own initiative.
- Experience / training in problem solving and clinical environment considered a plus.
- Experience in mentoring/guiding team members.
To apply for this position please contact Kim Hennessy at Sigmar Recruitment T: +353 91 455306 E: firstname.lastname@example.org
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