Sr/Principal Quality Engineer

Our early-stage MedTech client is developing a first-of-its-kind electromechanical software device with the potential to transform patient care. They are seeking a Sr. or Principal Manufacturing Quality Engineer to play a critical, hands-on role in building a world-class manufacturing quality foundation. The role involves four key functions, with the new hire expected to fill two, depending on their skill set. The hiring manager is open to manufacturing-quality or supplier-quality experience. The goal is to have someone capable of supporting all backup functions as resource needs fluctuate.

Your role with the company:

• Manufacturing Quality (Day-to-Day Support): Primarily involves managing non-conformances from incoming inspection, disposition processes, root cause analysis with suppliers, drawing updates, and corrective actions for newly launching commercial products.

• Equipment and Inspection Methods: Updating and improving inspection plans for purchased materials, sub-assemblies, and finished goods, including Gage R&R studies for high-risk inspections.

• Supplier Quality (Next-Gen Product "Vanquish"): Identifying and assessing new suppliers, auditing, getting them on the approved supplier list, and ensuring clear understanding of inspection and data requirements.

• Future Growth (Post 1 year): Continued production support with expansion into in-house building, developing new procedures, maintaining supplier relationships (contract updates, scorecards, audits), and working on supplier cost-down projects.

Desired Profile:

• BS Degree in Engineering preferred but not required.

• Experience with CAPA, Validation, NCMRs, Root Cause Investigation, and Equipment/Inspection Method Experience (IQ/OQ, Gauge R&R, Inspection programs, and data analysis).

• It would be great if the person were also experienced in Supplier Quality and Quality Auditing, but it is not necessary if the other areas are strong.

• Some experience with software validation (for inspection programs) is a plus.

• An understanding of the flexibility and involvement required in a smaller company is essential.

• Technical Skills: Experience with standard capability analysis, JUMP software (nice to have), NetSuite (nice to have for ERP).

• Personality: Willingness to learn, adaptable, and a good personality fit for a small company environment.