Quality Assurance Specialist

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional 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 Quality Assurance Specialist is within our CMI Business Unit. This role will support site QA activities and primarily focus on one or more key quality subsystems, including document control, training, complaints, nonconformances, CAPA and/or supplier control.  This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

Responsible for implementing and maintaining the effectiveness of the Quality System.

Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.

Aid in implementing process improvements with respect to Quality Assurance processes.

Maintain Quality metrics as required.

Manage and/or assist with complaints, CAPA, change requests, NCMRs, deviations.

Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits).

Assist in determining quality attributes and requirements. May provide technical assistance.

Utilize quality management techniques to perform investigations and facilitate solutions.

Work with managers to coordinate training requirements for employees as required.

Manage training program and organizational chart as required.

Perform Quality System Training Requirements as needed.

Review/approve supplier surveys and make recommendations as required.

Assist with internal audits and agency audits.

Manage Document Control as required.

Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors.

Drives functional performance to ensure that cross-functional standards and expectations are met.

May assist in the training of personnel as directed by management.

Responsible for completing documentation in a timely manner and in accordance with business standards.

Manage equipment maintenance and calibration program as required.

Assist with equipment, process and facility qualification and validation activities as required.

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.

Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Carries out duties in compliance with established business policies.

Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

Perform other duties and projects as assigned.

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

BS/BA degree in chemistry, biology, or other scientific discipline or equivalent combination of education and work experience.

2 years’ experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment, preferably in vitro diagnostics.

4 years of relevant work experience in assigned subsystem(s).

Writing and Communication Skills (e.g. write technical reports, present data analysis).

Experience with MS Office including excel and power point.

Must be detail-orientated, self-motivated and available for flexible scheduling.

PREFERRED QUALIFICATIONS:

Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR.

Demonstrated initiative and problem-solving skills.

Ability or aptitude to use various types of databases and other computer software.

Strong organizational skills.

Ability to clearly, concisely and accurately convey communications.

Knowledge of quality management techniques and application.

Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.

COMPETENCIES:

Drives for results

Attention to detail

Initiative

Communication

Adaptability