Abbott Sr Quality Engineer in Temecula, California

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.

Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.

  1. May be responsible for implementing product stops & documenting release criteria

  2. Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.

May be responsible for risk analyses and FMEAs..

  1. Develops and implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects..

  2. Collects and analyzes Leads Manufacturing process defect dataProduct/Process improvement efforts (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.

  3. Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams

Accountability / Scope

(Influence/Leadership) Establishes and cultivates an extensive network of support to facilitate completion of assignments.

Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. May interact with vendors.;

(Planning/Organization) Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments.;

(Decision Making/Impact) Exercises 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.

Education / Experience

Bachelor's degree (Engineering) plus 5-7 years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.

  • Medical device, Quality Engineering experience

  • Risk Assessment (RAM) or Failure Modes and Effects Analysis (FMEA) experience a plus

  • Experience with writing/owning protocols and reports

  • New Product Development, R&D, or Design Controls experience

  • Statistical analysis, Data analysis (JMP experience a plus)

  • Process Validation and Test Method Validation (including Measurement System Analysis or GR&R) experience

  • Nonconformance report writing, CAPA, Root Cause Investigation/Analysis experience

(Technical/Business Knowledge (Job Skills)) Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/ relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.;

(Cognitive Skills) 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. Has a sound knowledge of various technical alternatives and their impact.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com