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
Supports quality system audits. Provides input to management review process. May perform other duties as required.
Scope of Responsibilities:
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.
Outputs contribute to reduced cycle times, improved 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; Design Input; Design Output; Design Verification plans, protocols, and reports; Design Reviews; Design Validation; Design History File support; Change control; Assessment of Change Request (ACR) Responses; Risk Management; Process Validations; 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; Liaise with Manufacturing Plants; Provide functional support to cross-functional teams; 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 relevant experience or a combination of equivalent education and
Minimum 7 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, MDD, 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
Top skills required:
Design control Exp.
Medical exp, Risk exp.
Exp with Statistical tools.