Quality Manager - Design Quality Engineering

Philips•Reedsville, PA

3d•$120,000 - $186,000•Hybrid

About The Position

Design Quality Manager. In this role you Will Lead a team of Design Quality Engineers in providing guidance to project teams both as a manager and as a Subject Matter Expert to Core Teams regarding Design Controls, related regulations and the internal processes. Your role: Leading a team of Design Quality Engineers regarding Design Controls, related regulations and the internal processes. Act as a “Super User” in the interpretation of the Design Controls process outside of specific projects as they apply to business needs. Support engineering development teams throughout the development lifecycle to ensure robustness in the design. Lead your team and work with others in the organization to develop and apply advanced statistical tools to measure and metric develops to support EU-MDR Part 88, other forms of trending analysis for rare events, and product reliability modeling. Perform Post Market Risk Assessment to determine the effect of product defects on field residual risk and assess against the company Safety Policy for acceptability/unacceptability. Must be able to present this to MT level Councils for review and approval. Facilitate Design Failure Modes Effects Analysis (FMEA) for diverse engineering teams involving software and hardware from system level to unit level.

Requirements

Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.
5+ years of relevant experience in the field including demonstrated leadership and people management skill set.
Strong mastery of Quality principles such as the structure and topic areas of a Quality System, CAPA, Reliability, Root Cause investigation concepts and tools, etc.
Ability to teach, mentor and provide expert application of Design Quality concepts and tools such as Verification vs. Validation, Requirements Development and decomposition vs. Specification development, Safety Risk Management and FMEA.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
For this position, you must reside in or within commuting distance to Cambridge MA, Bothell WA, Reedsville PA, Plymouth MN, San Diego CA.

Nice To Haves

ASQ CQE, CRE, CQM or related certifications are a plus.
Preferred experience with EU-MDR, 21CFR820, ISO 13485, ISO 14971/TS 24971, IEC 60601, IEC 62366, IEC 62304, IEC 60812/VDA FMEA Handbook.

Responsibilities

Leading a team of Design Quality Engineers regarding Design Controls, related regulations and the internal processes.
Act as a “Super User” in the interpretation of the Design Controls process outside of specific projects as they apply to business needs.
Support engineering development teams throughout the development lifecycle to ensure robustness in the design.
Lead your team and work with others in the organization to develop and apply advanced statistical tools to measure and metric develops to support EU-MDR Part 88, other forms of trending analysis for rare events, and product reliability modeling.
Perform Post Market Risk Assessment to determine the effect of product defects on field residual risk and assess against the company Safety Policy for acceptability/unacceptability.
Must be able to present this to MT level Councils for review and approval.
Facilitate Design Failure Modes Effects Analysis (FMEA) for diverse engineering teams involving software and hardware from system level to unit level.