Senior Quality Engineer

·        As directed by the Quality Manager, the Senior Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices.

·        This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and Business Unit policies while meeting all design control and other regulatory requirements

·        Provides support/mentoring/coaching for application of technical principles, theories, concepts and quality tools and systems.

·        Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity.

·        Is a core team member for complex design control / process control projects. Can serve as a CAPA expert.

·        Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.

·        Supports quality system audits.

·        Provides input to the management review process may perform other duties as required

·        Develops advanced technological ideas and guides their development into a final product, process, or business opportunity.

·        Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work

·        Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context

·        Contribute to reduce project cycle times, improve effectiveness and furthering the achievement of goals critical to company objectives

·        Position specific responsibilities include support of the following, however, are not limited to:

·        Design Control

·        EU MOD/MOR

·        Change control

·        Risk Management

·        Process Validation

·        Identification of CTQ's

·        Handling of deviations and non-conformances

·        Test method validations

·        Supplier qualification

·        Post Market Surveillance

·        CAPA- Root cause investigation and implementation of corrective / preventive actions

·        Proper Use of Statistics (Sampling Plans)

·        Advise on Regulations and standards

·        Liaise with Manufacturing Plants

·        Provide functional support to cross-functional teams G Support Internal and external audits

·        Sphere of Influence

·        Work is performed without appreciable direction.

·        Assignments are often self-initiated.

·        Determine and pursue courses of action necessary to obtain desired results.

·        Plans and participates in disciplines strategically relevant to the business and/or functions

·        Provides advice and mentors junior Associates

·        Participates in, and may provide leadership for, multi-disciplinary projects

·        Considered Site / functional level Subject Matter Expert.

·        May be assigned as site / functional extended team member

·        Bachelor's Degree

·        A minimum of 9 years of relevant experience or a combination of equivalent education and relevant experience

·        Minimum 2 - 3 years of experience supporting design assurance for medical devices

·        Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements.

·        Applicable Regulatory and Industry standards (21-CFR-820, ISO '13485, MOD, MOR, ISO 14971,ISO 10993, etc.)

·        Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication

·        ASQ Certificate(s) desirable (but not required)

·        Design for Six Sigma preferred