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Abbott · 6 hours ago

Senior Quality Engineer

Minnetonka, MN

Full-time

Onsite

Mid, 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 Sr. Quality Engineer position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements

Lead, coach, and mentor non-exempt and entry level exempt personnel

Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues

Design and conduct experiments for process optimization and/or improvement

Appropriately document experiment plans and results, including protocol writing and reports

Lead process control and monitoring of CTQ parameters and specifications

Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)

Lead the investigation, resolution and prevention of product and process nonconformances

Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)

Lead in the completion and maintenance of risk analysis

Work with design engineering in the completion of product verification and validation

Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities

Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Performs other related duties and responsibilities, on occasion, as assigned

Qualification

Quality EngineeringSix SigmaLean ManufacturingFDA RegulationsISO 13485ISO 14971Statistical AnalysisProject ManagementCommunication SkillsInterpersonal SkillsLeadership SkillsOrganizational Skills

Required

Bachelors Degree (± 16 years) in an Engineering or Technical Field or an equivalent combination of education and work experience

Minimum 5 years

Engineering experience and demonstrated use of Quality tools/methodologies

Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971

Solid communication and interpersonal skills

Strong project management and leadership skills, including the demonstrated ability to lead multi departmental project teams and resolve quality-related issues in a timely and effective manner

Advanced computer skills, including statistical/data analysis and report writing skills

Ability to work in a highly matrixed and geographically diverse business environment

Ability to work within a team and as an individual contributor in a fast-paced, changing environment

Ability to leverage and/or engage others to accomplish projects

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Multitasks, prioritizes and meets deadlines in timely manner

Strong organizational and follow-up skills, as well as attention to detail

Ability to maintain regular and predictable attendance

Preferred

Demonstrated supervisory experience

Prior medical device experience

Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)

Experience working in a broader enterprise/cross-division business unit model

ASQ CQE or other certifications

Benefits

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.