Senior Quality Assurance Specialist in Cornholme

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self and live a full life.

Working at Abbott offers career development with an international company where you can grow the career you dream of. 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. Abbott is recognised as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

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.

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, analyse 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.
• Make timely and effective decisions related to business issues within scope of responsibility; appropriately elevate high risk issues / decisions; identify and quantify risks and their consequences relative to the success of a project / task; recommend appropriate action.
• Support equipment, process and facility qualification and validation activities as required.
• Support external agency and internal audits as needed.
• Support new product introduction activities.
• Assist 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.
• Understand and be aware of the quality consequences which may occur from the improper performance of their specific job.
• Demonstrate 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 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

• 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.

Compensation

Base pay: $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives. Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.