Job Description

Who we want

* Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
* Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

As a Staff Quality Engineer Operations you will provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Additionally, you will support supplier quality issues impacting daily operations; advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.

IF you are driven by quality and think holistically about improvements to product and process please APPLY now!

* You will work closely with operations and the business functions to ensure quality performance of product and processes.
* You will collaborate with divisional QA and supplier teams to address top quality issues cross functionally
* You will own identified internal and supplier non-conformances and manage the timely closure of NC's.
* You will own identified internal CAPAs and manage to timely root cause investigation, implementation, and closure.
* You will disposition non-conforming product within MRB, issuing NC's as appropriate.
* You will develop and improve internal manufacturing processes for existing products.
* You will perform PPAP activities for supplier changes
* You will maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.
* You will support and drive Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
* You will engage and interface in internal and external audits providing subject matter expertise
* You will support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
* You will be responsible for initiation, internal containment, and support of Commercial Holds for potential product escapes.

What you will need:

* Bachelors degree in Engineering or related discipline (Electrical Engineering highly preferred)
* 4+ years of experience in quality and/or manufacturing engineering a must
* Experience in electronics (PCBAs, flex boards, soldering, etc.) highly preferred
* Production process controls experience preferred
* Validation knowledge/experience (PPAP, IQ/OQ/PQ) preferred
* MS, CQE, or CRE preferred.
* Six Sigma Green or Black belt preferred.
* Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.