Quality Manager

Lightera • Avon, CT

1d

About The Position

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.

Requirements

• Bachelor’s degree in Engineering, Quality, or related technical field.
• 8+ years of progressive quality experience, including 3+ years in a leadership role within high-mix manufacturing.
• Demonstrated ownership of ISO 13485 and/or AS9100 certified QMS; audit leadership experience (internal/third-party/customer).
• Hands-on expertise with CAPA, risk management, FAI (AS9102), validation (IQ/OQ/PQ), and SPC/MSA.
• Proficiency with 8D, root-cause analysis tools, and data-driven decision-making.
• Knowledge of blueprint reading, GD&T, complex assemblies, and tolerance analysis.
• Excellent communication skills and experience collaborating with customers and executive leadership.

Nice To Haves

• Advanced degree or certifications: ASQ CQE/CQA/CMQ/OE, Lead Auditor (ISO 13485 or AS9100), Six Sigma Green/Black Belt.
• Experience in medical device and aerospace/defense environments simultaneously (mixed compliance).
• Familiarity with ITAR/EAR export controls.
• Experience implementing or migrating eQMS or MES, including Part 11-compliant workflows.
• Working knowledge of sterilization or biocompatibility processes

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• Serve as the voice of quality to customers: manage escape investigations, RMAs, complaints, and customer scorecards; drive proactive quality plans per contract.
• Support program launches and transitions, ensuring deliverables (FAI/PPAP, FAIRs, CoC/CoA, DMR updates) are right-first-time.
• Own quality data analytics and leading/lagging indicators; publish actionable insights for operations.
• Administer or partner on QMS/ERP/PLM/MES platforms, including electronic records/signatures.
• Oversee metrology and calibration systems; ensure gage lifecycle management and suitability for tolerance stacks common in high-complex assemblies.
• Develop a high-performing quality team: recruiting, coaching, training, succession planning.
• Build a quality-first culture that balances compliance, speed, and customer focus; influence cross-functional leaders and production teams.
• Promote EHS practices and safe quality—correct risks promptly and model safe behaviors.

Benefits

• Competitive salaries and generous benefits programs, including health, dental, vision and well-being.
• Company-sponsored 401(k) plan with a generous match and no vesting period.
• Tuition assistance, on-the-job training and opportunities for growth and advancement. We promote from within. 
• Generous Paid Time Off (PTO) program and paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager