Abbott Molecular has a new opening for PrincipalQuality Engineer. This role assures new or modified products conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
• Define and lead on-time completion of Design Control Deliverables
• Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
• Identify and drive opportunities to improve the quality system as it relates to design control deliverables including risk management
• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
• Define and lead Risk Management activities from product Concept through Commercialization
• Drive best practices for design test and inspection method development, and lead method validation activities
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Support manufacturing process development & qualification for new product commercialization and product changes
• Support and ensure internal & external audit responses
• Support and ensure on time product re-certifications
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
• Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
• Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
• Complete Document Change Request Reviews in a timely and objective manner
• Mentor, develop and lead other team members.
• 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.
Education and experience requirements
• Bachelor level degree in Engineering or Technical Field; advanced degreepreferred; Certified Quality Engineer is preferred
• 8+ years experience --
Equipment R&R; test method development, test method validation, test method control, sampling plans, independent reviewer, inter/external test methods
• Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
• Detailed knowledge of FDA, GMP, and ISO 13485
• Solid 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
• 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.