SHIFT: 6am – 2:30pm, M-F.  Saturdays on an as-need basis

Salary Range: $90k – $110k

A BRIEF OVERVIEW
The Manufacturing Quality Engineer is a key technical leader who strengthens the quality and reliability of client’s legacy products across all sites. This role pairs deep quality expertise with cross-functional influence by partnering with critical customers, guiding engineers through validations and new product introductions, and shaping the training and standards that elevate performance. The person in this role becomes a go-to resource for problem-solving, decision support, and quality strategy, with opportunities to lead initiatives that have site-wide and cross-site impact.

WHAT YOU WILL DO

• Leads or co-leads quality initiatives that align with site and corporate quality strategies, ensuring consistent adoption and measurable improvement.
• Provides direction, coaching, and technical mentorship to engineers, inspectors, and cross-functional partners to build capability and strengthen overall quality culture.
• Acts as a key decision-maker in escalated quality situations, balancing customer expectations, compliance requirements, and operational needs.
• Supports the Quality Manager in site-level planning, audits, and strategic reviews, stepping in as a delegate when needed.
• Drives cross-functional alignment during investigations, validations, and change management activities, ensuring teams stay focused, informed, and moving toward resolution.
• Provides and documents training on standard of work instructions, policies, and procedures in a timely manner to ensure team members have the required knowledge and skills prior to performing work independently.
• Uses quality tools to implement improvements including: process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques
• Acts as a customer liaison and processes customer quality complaints, as applicable.
• Collects, Analyzes, and Presents data using statistical methodology
• Assists suppliers with the interpretation of quality requirements, as applicable.
• Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including, but not limited to: complaint analysis, risk analysis, failure mode and effects analysis, CAPA, and process/equipment/software verification / validation
• Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Determines machine and/or process capability through planning and/or executing Process Capability studies
• Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics, associated sampling plans, and required gauging.
• Interfaces with appropriate customer contacts to clarify customer requirements
• Conceives and/or Leads productivity improvements and/or Continuous improvement projects
• Monitors engineering production processes and products for adherence to internal and external requirements and practices.
• Participates in pre- and post-production launch reviews providing quality engineering support
• Performs quality reviews and internal audits; evaluates data and writes associated reports
• Recommends modifications to existing quality or production standards, where applicable, to achieve optimum quality within limits of equipment capability.
• Reviews and approves product/process and document change requests.
• Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance, proper use of process and material specifications, and key characteristics for inspection plans and gauging techniques.
• Supports measuring and analyzing key metrics to monitor performance.
• Works with cross-functional teams to solve production and quality problems.
• Creates and manages the overall course structure and sets up course programs based on specifications.
• Reinforces safety expectations. Ensures safety operating practices are demonstrated. Reports issues/concerns to Supervisor.
• Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

EDUCATION QUALIFICATIONS

• Bachelor of Science (B.S) (Required)
• Master of Science (M.S) (Preferred)

EXPERIENCE QUALIFICATIONS

• 5+ Years of Experience (Required)
• 5+ Years of Experience in a Manufacturing Environment (Preferred)
• Experience in Medical Device Manufacturing (Preferred)
• Experience leading a team (Preferred)
• Experience managing change in a complex environment (Preferred)

LICENSES AND CERTIFICATIONS

• Any Quality Certification (Preferred)

KNOWLEDGE & SKILLS THAT ENABLE SUCCESS

• Operational Functions – Extensive Experience
• Quality Management – Extensive Experience
• Process Management – Working Experience
• Communication – Working Experience
• Accuracy and Attention to Detail – Working Experience
• Manufacturing Safety – Extensive Experience
• Lean Manufacturing – Working Experience
• Statistical Analysis and Measurement – Working Experience
• Production Part Approval Process (PPAP) – Working Experience
• Production Runs – Extensive Experience
• Final Inspection – Working Experience
• Computer Knowledge – Working Experience
• Customer Communication – Working Experience
• QSR and ISO – Extensive Experience
• Coaching – Working Experience
• Information Processing – Working Experience
• Lean Assessment – Extensive Experience
• Problem Solving – Working Experience

PHYSICAL DEMANDS

• Must be able to remain in a stationary position – Frequently
• Must be able to move about the inside of the building – Occasionally
• Must be able to move equipment around the building – Rarely
• Must be able to ascend/descend stairs or ladders – Rarely
• Must be able to position oneself and move under/around/over equipment – Rarely
• Must be able to handle/adjust/inspect/position various items and equipment – Rarely
• Must be able to communicate and exchange information with others – Constantly
• Must be able to perform tasks that require repetitive handling/adjusting/inspecting/positioning of items and equipment – Occasionally
• Must be able to distinguish and detect information such as writing and defects – Constantly 

ADDITIONAL REQUIREMENTS

• Candidates offered employment may be required to submit to a pre-employment background check and pre-employment drug-screening based on position requirements
• Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time
• Candidates must be able to provide proof of eligibility to work in the United States through eVerify