Abbott · 5 hours ago
Quality Engineer II
Plymouth, MN
Full-time
Onsite
Entry, Mid Level
$61K/yr - $123K/yr
2+ years expAbbott is a global healthcare leader that helps people live more fully at all stages of life. The Quality Engineer II will be 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
Lead the investigation, resolution, and prevention of product and process non‑conformances by applying systematic problem‑solving methodologies, driving effective communication, and implementing robust quality assurances and process controls utilizing the CAPA system to meet or exceed internal and external requirements
Expected to have a presence on the manufacturing floor and collaborate with Operators/Group Leads/Supervisors to drive meaningful improvements reinforcing key behaviors and Quality excellence
Lead in the completion and maintenance of risk analysis document(s) related to the manufacturing process(es)
Lead and implement continuous improvement initiatives across product and process areas to enhance performance and support efficient manufacturing operations
Support the completion of validation protocols and reports while leading or supporting manufacturing operations through the successful execution of product verification and validation activities
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
Assist in the development and execution of streamlined business systems and advanced technology which effectively identify and resolve quality issues
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
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
2-5 years Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Strong communication and interpersonal skills
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
Preferred
Prior medical device experience preferred
Experience working in a broader enterprise/cross-division business unit model 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 a 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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