Description
I have an immediate opening for a Senior Quality Systems Engineer with a leading medical device company based in Dublin. (Salary €40K-€50K). This is an excellent opportunity to join a well established international company that offers excellent benefits and state of the art facilities to all employees.Purpose:
To provide in-depth quality and regulatory expertise for significant site or inter-site projects. Be acknowledged as a quality & regulatory technical expert and take responsibility for training/education/motivation of affected personnel. Act as mentor/consultant for quality engineers & auditors/technicians.
Take responsibility for significant elements of the Management System.
Administer and lead the internal audit function including follow-up on outstanding audits, corrective actions and the maintenance of procedures and practices to current corporate and industry wide best practice.
Assist in, or lead, the development and administration of policies, procedures & processes to enhance the quality system on site.
Responsibilities:
- As the lead auditor, this position provides much of the information to determine process and product compliance and therefore, impacts organizational perception of SHDML and customer perception of SHDML.
- You will be a key contributor to the continuous improvement of the site quality system as a business value-added process.
- You will have shared responsibility for both internal & external audit control systems to ensure continued compliance and identify potential weaknesses.
- You will help develop and complete quality objectives for the site in line with the quality policy and strategy.
- You will maintain and improve the site quality system and manage the relationship between the site and global quality systems.
- The successful candidate will assist in the development of Engineers, internal auditors and technicians.
- There will be a requirement to participate in cross functional Global Internal Audit Team and other global projects teams as required.
Requirements:
- The ideal candidate will have a degree in Science, Engineering or Quality Management.
- The successful candidate should have a minimum of 5 years experience in a multi-national leadership role in the manufacturing industry.
- A med-tech and med-devices or pharmaceutical background is highly desirable.
- QMS Lead Auditor qualified with IRCA registration desirable
- The successful candidate should demonstrate Lead Auditor skills to an internationally recognized standard.
- Demonstrate excellent analytical skills, judgment and has a good understanding of statistical techniques.
- In-depth understanding of GMP, quality system standards and various relevant government regulations is required.
- Excellent communications skills, both verbal and written.
- Excellent attention to detail is imperative.
- Use of technical expertise and applied knowledge to influence key decision makers on the site and within the functional group regarding process and product compliance
If you are interested in hearing more about this exciting opportunity please apply directly to this advert or contact Derek Sheridan on for further details.