Senior Quality Systems Engineer (Temporary Maternity Cover)

Veryan Medical; Galway; Hybrid; EUR 90,000 - 110,000; Full time

Benefits offered by this job

Pension scheme with generous employer

Private medical insurance for you and/

Job summary

Veryan Medical in Galway, hybrid role, is seeking a Senior Quality Systems Engineer to ensure our quality management systems scale as we grow. Reporting to the Quality Systems Manager, you will lead CAPA/complaints coordination and assist with audits.

The ideal candidate has a Diploma level in engineering/science or QA and at least five years in medical device or pharma, with knowledge of ISO13485 and related regulations. Excellent communication and integrity are essential.

Qualifications

• Diploma level in Engineering, Science or Quality Assurance.
• Five years' experience in medical device or pharmaceutical industries.
• Familiarity with ISO13485, ISO14971, MDR 2017/745 and 21 CFR Part 820 desirable.
• Strong communication and organisational skills; ability to present reports clearly.

Responsibilities

• Review Quality System records for completeness and compliance.
• Support investigations and root cause analysis activities.
• Generate and analyse Quality System metrics.
• Participate in continuous improvement initiatives.
• Other activities as required.

Skills

Quality management

Regulatory knowledge

Communication

Education

Diploma level in Engineering/Science/QA

Job description

Full time (39 hour)- Temporary maternity cover role

Initial 6 month contract with possibility for extension

Galway (Hybrid)

We have an exciting opportunity for a Senior Quality Systems Engineer to join Veryan Medical!

Summary

Veryan Medical is a fast-paced, rapidly growing medical device company offering a highly differentiated solution in SFA interventions. We share a commitment, a passion, and a vision for the contribution Veryan makes to innovation in interventional medicine.

Our team powers Veryan's business. Whether sales representatives, design engineers, quality engineers, or clinical study managers, our people bring an unmatched expertise in each of their fields that both inspires and challenges.

Veryan's culture of innovation helps each individual develop both professionally and personally, and our culture of respect means that we all work in a collaborative, empowering, and exciting environment. We are committed to excellence through our patient-centric approach, and we pride ourselves in our integrity of doing what is right and doing what we say.

Reporting to the Quality Systems Manager the role of Senior Quality Systems Engineer is a crucial one in Veryan to ensure that our company systems and procedures are compliant as we scale and grow.

Job Requirements

• Support maintenance of the Veryan Quality Management System.
• Act as CAPA/Complaint/Temp coordinator as required.
• Lead /support the following activities as required:

• Complaints
• CAPA
• Internal Audits
• External Audits
• Document Control
• Training
• Change Control
• Software Validation
• Regulatory Reporting support
• PMS support
• Other activities as required.

• Review Quality System records for completeness and compliance.
• Support investigations and root cause analysis activities.
• Generate and analyse Quality System metrics.
• Participate in continuous improvement initiatives.
• Other activities as required.

Education & Training

• Educated at minimum to a Diploma Level in Engineering, Science or Quality Assurance discipline.

Experience

• A minimum of five years' relevant experience in the medical device or pharmaceutical industry.
• Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and 21 CFR Part 820 is desirable.
• Good communication and organisational skills, and the ability to present reports neatly and accurately is essential.
• Experience in management of Quality Systems activities, in particular Internal/ External Audit, Software Validation, Complaints, Risk Management and CAPA is desirable.

Benefits of Working with Veryan:

• Competitive salary and bonus payable on completion of your contract
• Pension scheme with generous employer contributions up to 8%
• Private medical insurance for you, spouse / partner and dependents
• Paid sick leave
• Long term disability cover
• Group life cover
• Annual leave of 23 days plus bank holidays increasing with service (pro-rata depending on length of contract)
• Active Sports and Social Committee with a schedule of events taking place during the year
• Hybrid working - on average 50% of time or 2/3 days a week on site in our state-of-the-art facility in Parkmore
• Flexible start and finish times
• Opportunities for further education, training and development

Company Values

• Empowering
• Acting with Integrity

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