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• The Senior Quality Systems Engineer 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. Provide quality assurance (QA) and quality engineering (QE) support to respective Product Line(s). Serves as a subject matter expert on the requirements and processes that result in the integration of the voice of the customer into the design and realization of products. Provides ownership for successful integration of appropriate Risk Management considerations into both design controls and issue resolution. Monitors field product performance for emerging trends and improvement opportunities for application to new product designs.
o Leads and participates in new product development process by ensuring that all the quality data streams are fully comprehended and that the voice of the customer, as heard through these data streams (complaints, non-conforming records [NCRs], verified failures, etc.), is a design input and consideration.
o Define and lead on-time completion of Design Control Deliverables.
o Provide subject matter expertise and ownership for Risk Management activities, including, the comprehensive and accurate assessment and characterization of design risks, which includes both the appropriate mitigation activities and proper identification in downstream design outputs (design failure modes and effects analysis [DFMEA], Critical To Quality and Critical To Process characteristics on specifications, Risk Assessments for issues impacting distributed product, etc.).
o Represent the QA/QE function for the review and approval of designated design outputs
o Lead and support all activities as required to ensure successful transfer of design to manufacturing and responsible for transfer to sustaining engineering.
o Create and ensure on-time execution of Quality Plans for internal development, OEM-based and design change projects
o Identify and drive opportunities to improve the quality system as it relates to design control deliverables including risk management
o Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
o Define and lead Risk Management activities from product Concept through Commercialization
o Drive best practices for design test and inspection method development, and lead method validation activities
o Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
o Support manufacturing process development & qualification for new product commercialization and product changes
o Support and ensure internal & external audit responses
o Support and ensure on time product re-certifications
o Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
o Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
o Accountable for development, execution and analysis of biocompatibility and sterilization qualifications
o Complete Document Change Request Reviews in a timely and objective manner
o Mentor, develop and lead other team members.
o Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
o 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.
o Additional duties may be identified by functional management based on the current project/business objectives.
o Bachelor level degree in Engineering or Technical Field; advanced degree preferred
o 5+ years experience
o Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
o Experience working in a broader enterprise/cross-division business unit model preferred.
o Ability to work in a highly matrixed and geographically diverse business environment.
o Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
o Ability to leverage and/or engage others to accomplish projects.
o Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
o Multitasks, prioritizes and meets deadlines in timely manner.
o Strong organizational and follow-up skills, as well as attention to detail.
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