Product Quality Assurance Analyst

Position: Product Quality Assurance Analyst

Location: Dundee

Salary: 13.59� ph

Hours: Mon to Fri - 37.5 pw

The Role:

The position of Product Quality Assurance Analyst is within Abbott's Cardiometabolic and Informatics Business Unit. The role will be based at Abbott Dundee, but its function is to support Abbott Diagnostics Technologies AS located in Oslo, Norway.

This role is focused upon complaint management for clinical tests (HbA1c, ACR, Lipid) and instrumentation (Afinion) forwarded from frontline communications with established intake sites, their investigation and closure within a dedicated complaint management system.

The ideal candidate will be detail orientated, produce accurate records, have excellent collaboration skills and will enjoy routine work tasks.

Full training the complaint investigation and management process will be provided.

minimum qualifications / education / experience

Bachelor's degree in natural sciences or equivalent technical discipline.

Lack of appropriate education level can be replaced / supplemented by 1 - 3 years' internal

Responsibilities:

• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
• Main responsibility is review, evaluate, investigate and close complaints, incl. escalate potential reportable events for evaluation of reportability
• Respond to inquiries regarding ATN products from customers and employees in other parts of the company
• Attend meetings with the intake sites and perform active product follow-up with them
• Perform customer data analysis to identify product and market related trends as part of requested complaint searches, e.g. as part of CAPA investigations
• Perform product specific troubleshooting training as needed

Minimum Qualifications:

Bachelor's degree in natural sciences or equivalent technical discipline.

Lack of appropriate education level can be replaced / supplemented by 1 - 3 years' internal experience in related fields, or demonstrated ability and motivation to learn.

Preferred BUT not essential qualifications:

• Experience in complaint administration
• Experience from work with quality assurance, regulatory, production and/or quality control according to GMP / ISO 13485 requirements
• Knowledge of diagnostics products' technology, applications and expected performance

Personal Competencies:

• Good ability to take initiative and work independently
• Good ability to analyze, and understand the customers' needs
• Good documentation skills
• Precise and systematic
• Enjoy routine work tasks

Randstad Business Support is acting as an Employment Business in relation to this vacancy.