Quality Manager

LIGHTERA has one of the longest and most respectable corporate lineages in American business, which goes back to Alexander Graham Bell and the invention of the telephone more than a century ago.  We have a proven track record of being first in the industry with application specific fibers, optical connectors, ribbon cables, erbium doped fibers, Raman fiber lasers, fiber gratings and more.  Our mission is to provide leading optical innovations and solutions by designing, manufacturing and supplying the best optical fibers, fiber cable and components and devices for our customers, with exceptional service that creates value for our shareholders, customers and employees.  To do so, we must continue shaping the future of communications by applying the best minds to the challenges our customers will continually face.

 

We currently seek a Quality Manager to join our division located in Avon, CT, and help support our continued business growth. 

 

This position is a hands-on leader responsible for the development, maintenance, and continual improvement of our integrated Quality Management System (QMS) to meet and sustain ISO 13485 and AS9100 certifications. This role drives product and process quality across a high-mix, high-complexity manufacturing environment serving regulated markets. The Quality Manager partners closely with Operations, Engineering, Supply Chain, and Program Management to ensure compliance, mitigate risk, improve yield, and elevate customer satisfaction.

 

Essential duties and responsibilities include, but are not limited to:

 

Quality Management System (QMS)

• As the QMS Management Representative, own the QMS to ISO 13485 and AS9100 requirements, ensuring alignment across procedures, records, and metrics.
• Lead Management Reviews, Quality planning, KPI alignment, and continuous improvement roadmaps.
• Ensure robust Document Control and Change Control (ECO/ECN) processes, including review/approval workflows and training effectiveness.

 

Compliance, Audits & Regulatory

• Lead or support third-party certification audits, customer audits, and regulatory inspections; manage audit schedules and responses
• Maintain compliance with FDA 21 CFR 820 (as applicable), AS9100, and customer-specific quality clauses.
• Oversee CAPA, nonconformance (NCR), and complaint handling; ensure timely, effective root cause and verified closure.

 

New Product Introduction (NPI) & Advanced Quality

• Integrate quality into the NPI lifecycle: phase-gate reviews, risk management, PFMEA/DFMEA, control plans, validation protocols (IQ/OQ/PQ), and special characteristics management.
• Establish First Article Inspection (FAI) and PPAP/APQP where required for aerospace programs.
• Define and deploy receiving/in-process/final inspection strategies tailored to high product mix with variable routings and cycle times.

 

Manufacturing Quality & Continuous Improvement

• Champion Statistical Process Control (SPC), MSA/Gage R&R, and data-driven problem solving (8D, 5-Why, Fishbone, DOE).
• Drive process capability (Cp/Cpk), yield improvement, scrap/rework reduction, and robust process validation/verification.
• Lead MRB and material disposition; ensure effective containment, root cause, and systemic corrective actions.
• Implement standardized work, error-proofing (poka-yoke), and digital quality workflows where practical.

 

Supplier Quality & Incoming Controls

• Build and manage the Supplier Quality Management system: qualification, risk-based audits, scorecards, corrective action, and development plans.
• Define incoming inspection sampling plans (AQL, risk-based), special process controls, and calibration integrity.

 

Customer Quality & Program Support

• Serve as the voice of quality to customers: manage escape investigations, RMAs, complaints, and customer scorecards; drive pro