Quality Engineer

Company : Katalyst HealthCares & Life Sciences

Location : New London, CT, 06320

Posted Date : 11 October 2025

Job Type : Other

Category : Industrial Engineering

Occupation : Quality Engineer

Job Details

Responsibilities:

The Supplier Quality Engineer is responsible for managing finished goods Contract Manufactured (CM) for Robotics Surgical Technologies.
Primary duties are focused on all QMS related matters pertaining to supplier selection, processing supplier change request, qualification, manufacturing, QMS development, and technical quality/service/costs improvements.
Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, SCR, Quality Plans, Control Plans, and FMEAs.
Represent the supplier quality engineering function to develop and execute the strategy to organize, direct, and report on all CM quality-related activities for contracted design and manufactured items made for the business.
Lead PPAP qualifications with the CMs.
Collaborate with CMs to develop robust SCAPAs.
Support the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAs.
Develop, implement, and monitor CMs/Supplier's development initiatives, including CM performance management, CM certification, process improvements, cost reduction, supplier forums, Six Sigma/Lean integration, audits, and selection activities, that align with the C&RM or/and business strategic goals and objectives.
Collaborate on New Product Development (NPD) teams to evaluate and understand future CMs and their associated quality and development plans.
Build and own the strategy for managing the CMs/Suppliers for the business.
Communicate with the business Quality lead on CM initiatives, updates, and issues.
Partner with Supplier Quality Managers to build a strategy for managing the CMs in all regions.
Ensure CM compliance with business Quality Systems and all relevant internal procedures and policies.
Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by CMs.
Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by CMs.
Develop, communicate, and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies, etc.
Ensure proper approval and documentation practices are followed for any process, material or tooling change (SCR - Supplier Change Request) at CMs.
Define and manage the process for growing effective "partnerships " with preferred CMs (to drive optimal performance) founded on common interest and which demonstrate trust, loyalty and financial success.
Lead by Example: Setting continuous-improvement driven mentality and solid quality culture for the organization.
Maintain compliance to set Key Performance Indicators for the business.
Maintain the highest level of compliance and operational standards set by the business.
Manage and report on CMs/Suppliers audit program in line with ISO and/or FDA 21 CFR part 820 regulations.

Requirements:

BS Engineering.
3+ years of Medical Device experience.
PPAP experience.
Process improvements.
Change requests.
Supplier evaluations.
Qualifying component changes.
CAPA, TMV, Control plans, PFMEA.
ISO13485 & GMP.
Robotics experience.