Specialist, QA Instrumentation

3 months ago

Manchester, United Kingdom Qiagen Full time

**Overview**
At the heart of QIAGEN’s business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.
Our most valuable asset are our employees - more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.
There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people’s lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

**Position Description**
A QA Specialist position has arisen for an enthusiastic, quality/detail driven colleague to join the Instrumentation team within the Quality Assurance department at QIAGEN Manchester on an 18-month fixed term contract basis. The successful applicant will join the team responsible for assuring the quality of QIAGENs instrumentation portfolio, working on IVD and Life Science products designed to make improvements in life possible.

We are ideally looking for individuals with a background in IVD instrumentation although applicants from regulated industries will be considered. The successful applicant will join a team of Instrumentation QA team members, with responsibilities both to the activities of the QIAGEN Manchester site as well as to the larger global organisation.

Key responsibilities:
Customer Complaints:

- Ensure that instrumentation complaint cases are reviewed and locked meeting international regulatory and ISO standards in a timely manner
- Act as instrumentation SME during the generation and update of QIAGEN complaint SOPs

QA Investigations:

- Assist in QA investigations including Root Cause Analysis to resolve product issues in line with ISO Standards, Regulatory requirements and QIAGEN SOPs

Post Market Surveillance:

- Responsible for completing QA tasks for instrument post market surveillance reports

Recall Management:

- Act as recall coordinator for the instrumentation products of which QA Manchester are responsible. Tasks including:

- Customer list generation
- Customer notification
- Regulatory query tracking and follow up
- Internal and external customer query follow up
- All company notification

Internal Audits:

- Participate in internal audits

External Audits:

- Support in the back office during notified body and customer audits when required.

**Position Requirements**
Essential
- Experience of customer complaints from a QA or RA perspective
- Experience conducting QA investigations including root cause analysis techniques
- Excellent communication skills with the ability to work effectively with a global team

Desirable
- Post market surveillance and recall management experience
- Audit experience
- Experience of ISO13485 and Design Control processes

**What we offer**
At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

We offer:

- Possibility to develop in an international company
- Attractive pension
- Private Healthcare
- Private Dentalcare
- Gym membership contribution
- Access to an Employee Assistance Programme
- A range of retail discounts and offers
- Opportunity to join internal QIAGEN communities
- Enhanced maternity package
- Flexible working options
- Bonus/commission
- 25 days annual leave (potential to increase linked to service)

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.

Job Reference: EMEA03936

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