Abbott · 7 hours ago
Senior Supplier Quality Engineer
Plymouth, MN
Full-time
Onsite
Mid, Senior Level
$78K/yr - $156K/yr
5+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Senior Supplier Quality Engineer will be responsible for supplier selection, evaluation, and material qualification, contributing to the development and maintenance of supplier quality engineering practices that meet Abbott and regulatory requirements.
BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical
Responsibilities
Participate in or lead teams in supporting Supplier Development Quality program requirements (e.g., represent the Supplier Development Quality function as a Core Team Member)
Participate in or lead teams supporting new product development associated to supplier development and management
Provides engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures
Mitigates risk by working with the Suppliers to document Process Flow Charts, PFMEAs, and Control Plans
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Evaluates and develops Supplied Data Agreement, Skip Lot, Dock-to-Stock, CoC, and CoA partnerships with suppliers
Reviews and approves all supplied product drawings and component quality plans
Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements
Performs audits and re-assessment of suppliers each year per a defined schedule
Identifies supplier contacts and solicits required documents from suppliers
Tracks supplier responses and conducts follow-up and escalation as necessary
Conduct phone calls with supplier as needed to expedite responses or answer questions
Reviews current Quality Agreements and determines need to revise
Solicits revised Quality Agreements as determined
Obtains and analyzes performance and quality indications information from internal sources for each supplier
Prepares and submits required quality records and documents for closure and filing
Manages the development of supplied product inspection procedures and first article requirements
Assesses supplier capabilities through direct visits, technical discussions directed testing and quality system audits
Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions
Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews
Contributes and participates in supplier performance reviews
Applies sound engineering analysis and judgment to reduce the need for inspection in accordance with program policies
Works with Manufacturing engineering to assess and address purchased product issues
Design and conduct experiments for process optimization and/or improvement
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Contributes to the development, maintenance, and improvement of Abbott supplier development quality program policies, procedures, and forms
Qualification
Required
BS degree in Engineering or Technical Field or equivalent experience
5 + years of Engineering experience in a regulated industry
Ability to work in a highly matrixed and geographically diverse business environment
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
Ability to leverage and/or engage others to accomplish projects
Strong technical writing skills
Experience with root cause identification and problem solving
Preferred
Advanced degree preferred
Medical device industry experience preferred
Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
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
Prior medical device experience
ASQ CQE or other certifications
Benefits
Free medical coverage in our Health Investment Plan (HIP) PPO medical plan
An excellent retirement savings plan with high employer contribution
Tuition reimbursement
The Freedom 2 Save student debt program
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
Company data provided by crunchbase