Senior Quality Assurance Engineer – Galway

The Role

The Senior Quality Assurance Engineer will take the lead in implementing an improving the QA function throughout our client’s organization.

Responsibilities 

• Be the leader of Quality within assigned area. Act as the designate for the Quality Manager.
• Continuously promote quality and customer satisfaction in everything that the company does.
• Ensure the Quality System is effective for the products being manufactured and fully compliant with customer and regulatory requirements.
• Ensure all customer requirements are identified, clearly documented in our Client’s manufacturing documentation and effectively implemented.
• Provide expert quality input into validations, change management, problem solving and product disposition activities.
• Work with customers and suppliers on quality related issues and new product introduction projects. Ensure all dealings are professional and good relationships are maintained at all times.
• Investigate product/process quality issues that arise, including customer complaints. Ensure they are effectively resolved in a timely manner using our clients CAPA system.
• Ensure effective change control practices are implemented.
• Lead quality related projects ensuring that they are delivered on time and within budget.
• Be part of project teams. Deliver on commits to schedule and budget.
• Act as a Lead Quality Auditor. Perform Supplier Quality Audits. Act as a guide during customer and regulatory audits.
• Be an expert on-site for statistical analysis and problem solving.
• Ensure that continuous improvements are planned and implemented on an ongoing basis.
• Manage a team of Quality Engineers and Technicians. Coach and mentor the team.
• To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment

Requirements

• Degree in Engineering, Science or Quality.
• Relevant experience in a quality assurance role within the Medical Device Industry or similar regulated industry.
• A minimum of 7 years’ experience in a similar role.
• Proven track record in leading quality within a medical device manufacturing company.
• Ability to manage quality related projects.
• Proven track record in people management. Must be able to manage a team of up to 8 staff.
• Excellent attention to detail.
• Thorough knowledge of applicable regulatory requirements (ISO 13485, FDA etc.)
• Proven track record in problem solving. 6 sigma qualification (Green Belt of higher).
• Understanding of lean principles. Lean green belt an advantage.
• Excellent communication skills both verbal and written.
• A positive attitude in dealing with people.
• Ability to learn and adapt to various situations.
• Must be able to work under own initiative, with minimum supervision.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

Pale Blue Dot® Recruitment

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