Quality Engineer

Join to apply for the Quality Engineer role at Abbott
.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life‑changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

• Support QMS Implementation and maintenance of applicable distribution sites. Activities include documentation updates, new releases of documents, QMS reviews for audit preparation, participation in internal and external agency audits
• Reduces and controls distribution process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• Execute qualification/validation activities to support distribution projects and internal process implementation driven by the business units.
• Own and execute improvement activities (CAPA/NCMR), performing root cause analysis and implementation of solutions to mitigate risk.
• Analyze complex interdisciplinary problems and identify their impact, establish probabilities, draw conclusions reflecting broad business needs, and understand organizational and financial impact of recommendations (e.g., apply regulatory requirements and recommend best course of action).
• Responsible for product stops ship execution (containment, releases, disposition executions (scrap, rework, sort)).
• Develop and implement quality plans, documents and systems by creating quality specifications, risk analyses, FMEAs in conjunction with other cross‑functional teams.
• Responsible for risk analyses and FMEAs of distribution processes.
• Develop and implement Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of distribution defects and devising methods to reduce process variation in order to reduce or eliminate the cause of defects.
• Collect and analyze process defect data (e.g., scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development.
• Create Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
• Participate in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team.
• Participate in determining goals and objectives for projects. Influence middle management on technical or business solutions.
• Interact with business units/mfg sites to support product flow or dispositions through distribution plans and organize non‑routine tasks with approval.
• Initiate or maintain work schedule.
• Establish priorities of work assignments. Exercise judgment in selecting innovative, practical methods to achieve problem resolution.
• Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

• Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions and has a sound knowledge of various technical alternatives and their impact.

• Wide application of technical principles, practices, and procedures.
• Strong understanding of business unit function and cross group dependencies/relationships.
• Strong verbal communications to work with highly matrixed organization.
• Quality System experience related to implementation and/or maintenance of quality management systems for effectiveness.

• Associate's Degree (±13 years). (Field of Study or Equivalent)
• Minimum 4 years of experience.

The base pay for this position is $75,300.00 – $. In specific locations, the pay range may vary from the range posted.

• Mid‑Senior level

• Full‑time

• Quality Assurance

• Hospitals and Health Care