Staff Quality Engineer II

Summary:

As directed by the Quality Manager, the Staff Quality Engineer is accountable for supporting new medical electrical equipment /system development and maintenance through the application of Quality engineering skills for medical devices. This person will have prior knowledge and experience with medical electrical systems and 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/regulatory standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Responsibilities:

Provide coordination and guidance to cross functional teams to ensure product quality objectives are met

Extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measureable / confirmed results

Track record of root cause determination and effective corrective / preventive action implementation

Provides training for product development teams and continuous improvement team on best practices

Conducts audits as member of a quality system audit team (e.g. SME, etc.)

Writes and leads risk management activities including risk management reports, hazard analysis, and failure analysis

Support of the following, however are not limited to:

◦Design Control

◦Risk Management

◦Process Validations

◦Identification of CTQ's

◦Unit Quality Independent Reviewer During Design Reviews

◦Test method validations

◦Manufacturing equipment Software validations/Computer system validations

◦Proper Use of Statistics (Sampling Plans)

◦Advise on Regulations

◦Liaise with Manufacturing Plants

◦Provide functional support to cross-functional teams

◦Usability Engineering/Human factors

◦Reliability Engineering

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

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 core team or extended core team member

Qualifications

•Bachelor’s Degree in a technical discipline, preferably Electrical Engineering, Electronics, Biomedical Engineering or related discipline

•A minimum of 12 years relevant experience or a combination of equivalent education and relevant experience

•Knowledge of electrical systems, products, components, applications, component’s capabilities, electrical testing methods, testing finished products and system capabilities

•Demonstrate functional knowledge and expertise in product development, verifications, validations, reliability, human factors, regulatory requirements, international standards, and risk management

•Extensive knowledge of applicable regulatory (such as 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601 and IEC 62304) Corporate and / or Unit requirements

•Understanding of IEC-60601, IEC-62366 and IEC-60950

•Prior experience with Medical electrical system with software

•Prior experience with reusable medical devices

•Prior experience with reliability engineering testing

•Class II / III medical device experience

•Knowledge of design control principles

Preferred skills:

◦Demonstrated ability to support internal / external audits

◦Knowledge of six sigma methodology

◦Training in design of experiments and statistics

Certified Quality Engineer and Certified Quality Auditor

Compensation

Benefits - Full

Bonus Eligible - Yes

Interview Travel Reimbursed - Yes

Candidate Details

10+ to 15 years experience

Minimum Education - Bachelor's Degree

Willingness to Travel – Occasionally