My client seeks an advanced level of quality engineering in the business of medical device plastics injection molding.

SUMMARY:

The Advanced Quality Engineer - Healthcare will plan and direct all quality engineering activities for new product launches from disciplined requirements reviews through highly standardized IQ/OQ/PQ validation protocols.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

·         Work with Strategic Engineering Team, Business Unit Manager, the Technology Center, and Manufacturing, on advanced quality planning to effectively bring new programs from concept to production.

·         Work with customers to ensure advanced quality plans including critical dimensions, control plans, process flow diagrams, SPC plans, FMEA’s, etc. are initiated during the earliest stages of each program.

·         Manage inspection process (metrology) for assigned projects. 

·         Perform scientific validations including DOE’s and statistical analysis.

·         Work with plant based Quality Engineering Managers and Quality Engineers to ensure proper utilization of advanced quality planning tools consistent with ISO-TS procedures.

·         Actively seek responsibility for all aspects of Quality Engineering for all assigned customers and projects.

·         Assume accountability for meeting all ISIR and part submission dates.

·         Closely monitor and report project status (GYR format) to Engineering Manager on a weekly basis.

·         Participates in all engineering team program design reviews and weekly team meetings.

·         Performs other related duties as assigned.

Your background must encompass the following criteria

·         Experienced in injection molding tight tolerance medical parts and familiarity with sub-assemblies and contract manufacturing.

·         Preference given to individuals with engineering or technical degree and/or 10 plus years of hands on experience in precision molding and quality assurance.

·         Must have experience writing and carrying out IQ/OQ/PQ validation protocols.

·         Experience in a medical device or FDA regulated environment.

·         Preference given to individuals with demonstrated regulatory validation experience for Class II and Class III Medical Devices, including 510K submissions.

·         Preference given to individuals who are an ASQ Certified Quality Engineer, a Six Sigma Black-belt, or are currently pursuing certification.

·         Prefer this individual to have a working knowledge in Design of Experiments (DOE), and ability to implement theories during qualification phases of new programs.

·         Proficiency working with Microsoft Excel, Word, and other software products.

·         Experience with Minitab or other statistical software strongly desirable.

·         Skilled in metrology tools, and Geometric Dimensioning and Tolerancing (GD&T).

·         Must have working knowledge of probability and statistics, with college credits preferred.

·         Must be able to understand and interpret blueprints of plastic parts, assemblies and systems.

·         Able to work effectively in a team environment.