Advanced Precision Quality Specialist, Machined Components

Torrey Holistics; Berlin (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

TOMZ is seeking an Advanced Precision Quality Specialist to safeguard compliance across machining, assembly and anodizing processes for medical device components. You will lead inspections, document control, and help drive continuous improvement within a regulated manufacturing environment.

Role requires strong blueprint interpretation, meticulous data handling, and hands-on measurement with micrometers, calipers, and CMM basics.

Qualifications

• Ability to interpret blueprints, specifications and procedures.
• Relentless attention to detail and timely task execution.
• Solid math foundation and experience with precision hand tools.

Responsibilities

• Perform and teach visual/layout inspections using precision instruments; document results.
• Maintain ISO 13485 documentation and ensure traceability in all records.
• Review DHRs against DMR and enforce GDP/GMP during production and final release.
• Capture inspection data in ERP/QMS and ensure proper nonconformity handling.

Skills

Blueprint interpretation

Attention to detail

English communication

Mathematical proficiency

Education

High school diploma or GED

Manufacturing/engineering discipline preferred

5+ years in regulated manufacturing

Tools

Micrometers

Calipers

Dial indicators

Height gauges

Gages

CMM basics

ERP

QMS systems

Job description

Join the missionEvery component we release can influence a patient’s outcome. As an Advanced Precision Quality Specialist at TOMZ, you will be a frontline guardian of compliance and accuracy for medical device components manufactured through high‑precision machining, assembly, and anodizing.The challengeLead with clarity: Organize daily workload, define measurable goals, and mentor Quality Control teammates—coaching, correcting, and contributing to performance appraisals. Inspect with rigor: Perform and teach visual/layout inspections using microscopes, calipers, micrometers, and gages; execute advanced measurements via comparators, vision systems, contracers, and basic CMM. Document without compromise: Build and maintain ISO 13485 documentation; ensure robust material control, identification, and full traceability. Prove conformance: Review DHRs against the DMR; enforce GDP on Routers, Inspection Plans, and DHRs during production and at final lot release. Make data count: Capture inspection results in ERP and QMS systems; preserve electronic and physical records with strict control and traceability. Contain risk fast: Execute Incoming, In‑Process, and Final Inspections; record nonconformities; verify corrective follow‑up; escalate to MRB when necessary; oversee sorting to isolate issues. Automate smartly: Provide basic programming support for complex inspection and test routines to streamline repeatability and throughput. Validate firsts: Conduct First Piece and First Article Inspections (FAI) to qualify setups and processes. Audit and improve: Run process audits to confirm adherence to procedures/standard work; evaluate SPC, precontrol, tool life, and process parameters; teach best practices; drive CI aligned with GDP/GMP. Be everywhere: Move between departments and production lines as needed, bringing a proactive approach and unwavering safety mindset while following PPE requirements. Honor the system: Adhere to the TOMZ Quality Management System and support other quality functions and record retention as assigned.Your profileExpert at interpreting blueprints, specifications, and procedures.Relentless attention to detail and timely task execution.Hands‑on mastery of dimensional, visual, and mechanical inspection processes.Proficient with Microsoft Office; strong English communication skills (written and verbal).Solid math foundation and deep experience with micrometers, calipers, dial indicators, height and pin gages, and related precision hand tools.Background in Class I, II, and/or III medical device manufacturing and experience within regulated industries such as aerospace, defense, or pharmaceutical.Education and tenureHigh school diploma or GED (or directly transferable experience); manufacturing/engineering discipline preferred.5+ years in regulated manufacturing, or equivalent education plus experience.Preferred extrasASQ CQT, QCI, or comparable quality certifications.Applied knowledge of GMP and ISO standards.Physical requirements and environmentAbility to bend, stoop, squat, and kneel; lift up to 50 lbs (use team lift/mechanical assist for heavier items).20/20 vision (assisted or unassisted) needed to sort raw and nonconforming materials; steady dexterity for small to medium parts.Regular exposure to oils, grease, shop noise, cleaning agents, dust, metal particulates, sparks, coolants, and sharp edges; PPE like safety glasses, dust masks, ear plugs, and cut‑/chemical‑resistant gloves may be required.Comfort with extended standing or sitting and frequent computer/keyboard activity.