Senior Quality Operations Manager
Are you an experienced and highly motivated Senior Quality Manager within the Medical Device Industry? Are you tired of getting stuck in traffic going east through the tunnel to work? Are you looking to take the next step in your career, make a difference and be part of the Site Leadership Team? Then I might have the role for you!...
Expanding Medical Device Client, a short distance West of Cork City, have a newly created position of Senior Quality Operations Manager that will sit on the Site(SLT). You will lead the Operational Quality and Compliance department providing expert quality support to manufacturing operations, through developing and leading a high performing and engaged quality team. There are lot of NPI's currently being introduced to the site this year so it is a very exciting time to be joining. Amazing opportunity!
Permanent position, excellent salary & benefits package
Having recently visited the site, it very evident that this client has a very inclusive, positive and ''down to earth'' work culture that values ongoing collaboration, teamwork and encouragement. It genuinely is a lovely place to work, with a ''family feel'' to the Company but with the resources and support of a multinational.
- Lead and manage all tasks and activities related to Quality Operations within the site. Providing daily hands on technical support to the quality team.
- Provide guidance, coaching and mentoring in all areas of the QMS to all the Quality Operations team members.
- Develops and manages a high-performance quality engineering team. Creates a strong team working environment with focus on customer needs, compliance, product quality, and risk mitigation. Ensures staff are trained to perform effectively their work and their training is documented.
- Daily execution of quality practices and the maintenance of an effective quality system.
- Represent Quality through all product and process changes/improvements to help ensure product manufacturability, reliability and cost effectiveness.
- Provide Quality engineering support for manufacturing and project management.
- Drive continuous improvement initiatives to enhance the site quality system and product quality ensuring compliance to governing regulations and global policies and procedures.
- Participate in site projects in order to contribute to continuous improvement of the Quality system and facility. Assist in determining project scope, goal, and deliverables, identifies tasks, resources required and project plans with guidance from management
- Participate in cross-functional quality and business process improvements, integrating lean and best practices within the QA organization and supporting Global QA initiatives.
- Enhance and Promote the quality management system within the Organisation & Ensure adherence to regulatory requirements: RDC, ISO and FDA.
- Participate, as required, in the development, validation and improvement of the manufacturing processes for existing and new products and processes
- Participates in NCEs, CAPAs & Customer Complaint investigations when necessary
- Participate in new product introductions and provide quality support in these processes.
- Provide technical support to the product cleaning, clean room, packaging, labelling and dispatch operations.
- Apply proactive, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving/improving quality issues.
- Works cross-functionally to ensure the support of the production function. Delivers process improvements that reduce cost or improve the quality of the product.
- Overall responsible for all decisions relating to product quality including the disposition of non-conforming product.
- Manage and own budgets, plans and spend for the Quality Operations Dept.
- Relevant Engineering/Technical Degree (Level 8)
- Minimum 8 years experience in a similar Quality Management role within the Medical Device Industry
- Excellent communication, interpersonal, presentation and leadership skills with proven people management ability -exceptional team building/coaching/mentoring skills
- Analytical and technical expertise with proven problem solving (statistics, capabilities, sampling planning, validations, risk assessment etc)
- Strong attention to detail and decision- making ability
- Quality Systems experience