Process Quality Engineer

Job description

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

The Sr. Quality Engineer is responsible for supporting product development and manufacturing of electrical hybrid assemblies for implantable cardiac support systems or neuromodulation devices. The hybrids, support next assembly of products to include: pacemakers, defibrillators, cardiac monitors and neuromodulation devices. The Sr. Quality Engineer position focuses primarily on hardware quality, but also supports other aspects of product development.

This position is responsible for developing and maintaining quality engineering methodologies in an electronic manufacturing environment and providing quality engineering support within new product development, manufacturing, or quality systems support.

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 methodologies (e.g., Statistical Analysis, 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 various engineering teams to support production operations in a microelectronic manufacturing environment
• 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.

QUALIFICATIONS

Education Level

Bachelor's Degree (± 16 years)

Electrical Engineering or Technical Field

Or an equivalent combination of education and work experience

EXPERIENCE/BACKGROUND

Minimum 5 years

Demonstrated supervisory experience preferred. 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.

Experience in electrical contract manufacturing environment or equivalent and experience with electrical/microelectronic manufacturing processes. Fluent with electrical manufacturing standards (IPC/JEDEC, etc) and experienced with electrical component manufacturing, component analysis (XRF/SEM/X-Ray) and test.

Advanced computer skills, including strong statistical/data analysis and report writing skills. Prior medical device experience to include validation processes (IQ/OQ/PQ and design margin preferred. 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 preferred. 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.

ASQ CQE or other certifications preferred

JOB FAMILY:

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MEDICAL SURVEILLANCE:

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