I'm delighted to be working with a new client of ours on this amazing Quality Manager role. This position offers the successful candidate the chance to shape the role and continually innovate our quality standards, elevating them to World Class levels and aligning with best practices for improvement. This is a permanent position with strong salary package (€80,000 - €90,000 depending on experience) and the chance to join a growing medical device company in Wicklow. There has been high interest in this role already, so if you are interested in learning more, please email julieannfitzpatrick@sigmar.ie with your CV, or apply below and I will be in touch.
Responsibilities include:
- Manage and develop quality assurance systems as an adjunct to production led quality control for internal and external manufacturing.
- Ensure robust systems are in place to maintain compliance with customer specifications, the quality management system and best practice.
- Continue to develop and maintain quality standards for the business in line with ISO certification and best practice.
- Formalise and document all quality training and standards, provide and supervise all quality related training and drive strict adherence to these quality standards.
- Implementing and execute inspection, testing, and evaluation methods to ensure that products and materials adhere fully to these standards. Develop and regularly report to relevant KPIs to confirm adherence.
- Maintain an effective internal auditing system per the QMS requirements.
- Continue to develop and maintain route cause analysis and timely and appropriate permanent corrective action in any case of non-adherence to standard.
- Roster all quality staff according to production plan requirements and sign off on and expedite fortnightly payroll data for quality personnel to payroll processor in a timely manner. Ensure quality team are agile to manage changing customer requirements.
- Drive a continuous improvement ethos within the Quality department.
- Recruit all staff for quality positions with the assistance and involvement of HR.
- Implement and maintain a performance review process for all direct reports to include performance appraisal, retention and training. Identify any skill gaps and implement training to bridge such gaps.
- Liaise effectively and continuously with all other departments to effectively communicate the required quality standards and ensure strict adherence to these standards.
- Liaise directly with customers as a primary point of contact in QA.
- Lead investigation of customer complaints, implementing corrective and preventative actions in a timely manner and align with customer requirements.
- Provide oversight of external manufacturing by implementing and maintaining effective supplier quality measures.
Job Qualifications & Required Skills:
- Preferred 5-10 years Quality management experience with evidence of building strong relationships.
- Evidence of working knowledge of Lean / Continuous improvement / WCM.
- Evidence of working knowledge of ISO9001, ISO 13485 and cGMP.
- Experienced in QMS auditing to ISO 13485 or supporting on-site customer audits.
- In-depth knowledge of process validation.
- Strong attention to detail.
- Strong organizational skills.
- Ability to communicate complex quality related matters to wider team.
- A team player
Ideal Candidate
The ideal candidate will be energetic, driven and a skilled communicator with a visible sense of urgency in their daily routine, whose first thought will always be “is this in the customer’s best interest?”. Able to communicate effectively at all levels, unafraid to voice sometimes unpopular opinion, can think on his/her feet and is agile, to effect changes in the manufacturing schedule in line with changing customer or market requirements.