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Abbott · 18 hours ago

Senior Quality Assurance Specialist

United States - Virginia - Portsmouth

Full-time

Onsite

Senior Level

$78K/yr - $156K/yr

5+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Quality Assurance Specialist will support site QA activities and focus on key quality subsystems, ensuring compliance and leading process improvements.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

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

Qualification

Quality AssuranceRegulatory ComplianceQuality System RegulationsISO 13485ISO 14971MS OfficeProblem SolvingCommunication SkillsDetail-orientedCritical Thinking

Required

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 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

Master's 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

Ability or aptitude to lead without direct authority

Benefits

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

An excellent retirement savings plan with high employer contribution.

Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.