Senior Quality Assurance Specialist

JOB DESCRIPTION:

Senior Quality Assurance Specialist

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:

The position of Senior Quality Assurance Specialist is within our Toxicology Business Unit. The position will support site QA activities and primarily focus on one or more key quality subsystems including document control training launch process NPI complaints nonconformances CAPA and/or supplier control.

What Youll Work On

• Responsible for implementing and maintaining an effective Quality System.

• Leading and/or contributing to system product and process improvement projects.

• Independently lead groups and projects to resolve complex issues analyze complex problems and identify their impact establish probabilities draw conclusions reflecting broad business needs and ensure compliance.

• Cross-functionally lead Quality System process improvements which may include training corrective action and preventive action (CAPA) activities equipment maintenance product and process planning quality audits validation.

• Contribute to the development approval and implementation of product labeling and instructions for use as required.

• Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.

• Supporting equipment process and facility qualification and validation activities as required.

• Supporting external agency and internal audits as needed.

• Supporting new product introduction activities.

• Assisting in product launch and SKU discontinuation activities.

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

• Maintain Quality metrics as required.

• Provide support (management/execution) with CAPA change requests deviations and NCMRs.

• Work may require collaboration with other Division sites and/or other Abbott divisions.

• May manage training program.

• Manage complaints as required.

• Assist in managing supplier qualification program and support TPM management.

• Onboard suppliers per established supplier management procedures.

• Create and revise quality agreements and maintain supplier files.

• Support in supplier auditing activities.

• Perform Document Control activities as required.

• 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.

• 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.

Required Qualifications

• BS/BA degree preferably in science or engineering or chemistry biology or other scientific discipline

• Minimum of 5 years of Quality Assurance or Regulatory Compliance experience in a manufacturing/distribution environment preferably in vitro diagnostics or FDA regulated industry with 3-5 years progressively responsible positions

• Thorough knowledge and practical application of Quality System Regulations 21 CFR 820 ISO 13485 ISO 14971 and IVDD

• Strong knowledge of MS Office

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

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

• Strong communication problem solving and motivational skills

• Demonstrated initiative and problem-solving skills and critical-thinking skills

Preferred Qualifications

• Masters degree preferred

• Knowledge of quality management techniques and the application and principles of quality engineering

• Strong knowledge and application of concepts practices and procedures

• Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors

• Understanding of statistics

• Experience with product development risk management complaint management

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

• ERP experience (Sage or Great Plains preferred)

• Ability or aptitude to lead without direct authority

The base pay for this position is

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

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