JOB DESCRIPTION:

ABOUT THE POSITION IN ABBOTT

Abbott Diagnostics Technologies AS is part of Abbott Diagnostics, bringing together teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Supplier Quality Specialist is within our Cardiometabolic and Informatics Business Unit located in Oslo, Norway. This role will be responsible for quality activities for purchasing controls to assure the suitability and effectiveness to meet quality and business objectives.

RESPONSIBILITIES

• Carries out duties in compliance with established business policies and procedures.

• Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.

• Selects, qualifies and monitors suppliers including maintenance of the Approved Supplier List (ASL), monitors supplier performance, qualifies potential suppliers and oversees of supplier corrective action records (SCARs).

• Applies QSR 21 CFR Part 820 (Medical Devices) and ISO13485 to everyday application of Supplier Quality Management activities.

• Supports the creation and management of quality agreements with suppliers.

• Manages supplier change control and working with cross-functional teams to evaluate the change impact to product performance.

• Support and complete purchasing controls related QI and CAPA according to local procedures.

• Responsibility for specific tasks will be reflected in the employee’s training plan.

• Perform other duties and projects as assigned.

MINIMUM QUALIFICATIONS/ EDUCATION/ EXPERIENCE

• Bachelor’s degree in Life Science or engineering discipline

• IF APPLICABLE: Approved and valid background check from the Norwegian Civil Aviation Authority

PREFFERED QUALIFICATIONS

• Master’s degree in life science or engineering discipline

• A minimum of 2 years’ experience from regulated environment (medical devices and/or pharmaceutical) is required (ISO 13485, cGMP)

• Working understanding of regulations relating to in-vitro diagnostic medical device products (e.g. 21CFR Part820, ISO 13485, ISO 14971:2012)

• Experienced in root cause analysis and corrective action processes

PERSONAL COMPETENCIES

• Excellent written and verbal communication skills (both Norwegian and English)

• Ability to organize and prioritize workflow and to meet established timeframes

• Excellent analytical and problem-solving skills (root cause analysis, risk analysis)

• Proven ability to work effectively within a team environment while satisfying individual responsibilities and objectives

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

CMI ARDx Cardiometabolic and Informatics

        

LOCATION:

Norway > Oslo : Kjelsasveien 161

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable