Abbott · 10 hours ago
Staff Quality Engineer
Plymouth, MN
Full-time
Onsite
Lead/Staff
$99K/yr - $199K/yr
8+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Staff Quality Engineer will be responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development and manufacturing.
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 lower-level exempt personnel
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., Six Sigma and Lean Manufacturing)
Lead the investigation, resolution and prevention of product and process nonconformance’s
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
Manages & monitor site NCMRs/CAPAs including reporting requirements, provide detailed updates and information in support of quality, also liaising with other Abbott sites to ensure compliance to quality system
Perform or review manufacturing non-conformances reports, CAPA, failure investigations and audit findings to report manufacturing related issues that may impact quality and recommend courses of corrective action
Prepare metrics for NCMRs / CAPA suppliers’ performance, analyze process data and trends and drives optimization and improvement. Perform and report line defects trend analysis
Qualification
Required
Bachelor's degree in engineering or Technical Field with an equivalent combination of education and work experience
Minimum 8+ years' experience
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
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)
Ability to work in a highly matrixed and geographically diverse business environment
Ability to work within a team and as both a leader and individual contributor in a fast-paced, changing environment
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 preferred
ASQ CQE or other certifications preferred
Experience working in a broader enterprise/cross-division business unit model preferred
Prior medical device experience preferred
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.
Company
Abbott
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.79M2011-03-15Post Ipo Debt· $0.1M
2009-03-16Post Ipo Debt· $6.69M
1980-12-12IPO
Leadership Team
Robert Ford
President & Chief Executive Officer
Mike Peterson
Senior Vice President
Recent News
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