Precipart, located in Farmingdale, NY, Precipart is seeking a Senior Quality Assurance Engineer who will own product and process quality from new product introduction through serial production for tight-tolerance precision machined components and engineered assemblies. As a Senior Quality Assurance Engineer you will drive total quality, statistical rigor into manufacturing processes, eliminates variation at the source, and hold internal work cells to standard. The Senior Quality Assurance Engineer embeds on the shop floor as a daily resource to machinists, cell leads, and assemblers. This role maintains full ownership of quality planning, measurement systems, SPC, nonconformance disposition, and customer and regulatory compliance. The role partners directly with Engineering, Operations, Program Management, and Supply Chain and reports to Quality Department leadership.
ESSENTIAL FUNCTIONS
Shop Floor Engagement & Daily Operations
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Embed on the manufacturing floor as the first-line quality resource for machinists, assemblers, and cell leads on quality plan, in-process checks, and disposition decisions.
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Lead and sustain QRQC (Quick Response Quality Control) at the cell, line, and plant tiers. Drive same-shift problem identification, containment, and root cause initiation; escalate unresolved items into the formal NCR/MRB and CAPA pipeline with clear handoff criteria.
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Participate in daily Tier 1/2 meetings. Own the quality voice: scrap, rework, escapes, open NCRs, audit actions, and customer complaints. Convert tier-board signals into action with named owners and closure dates.
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Provide real-time bench support during setups, first-piece approvals, and process upsets. Authorize or hold production based on documented criteria.
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Train and certify operators on inspection methods, gage use, SPC chart interpretation, and reaction plans. Ensure training documentation is completed and maintained.
Quality Planning & New Product Introduction
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Author Control Plans, Inspection Plans, and PFMEAs aligned to APQP.
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Build CTQ matrices and requirements of traceability from customer drawing and specification through routing operations, in-process checks, final inspection, and PPAP/FAI deliverables.
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Lead First Article Inspection per AS9102 and collaboratively support/lead PPAP submissions; resolve rejections and drive resubmittal closure.
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Translate GD&T per ASME Y14.5 into measurement strategy, datum schemes, and gaging selection.
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Execute Test Method Validation (TMV) for inspection and functional test methods, including IQ/OQ/PQ where required, with documented acceptance criteria and statistical justification.
Metrology & Measurement Systems
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Specify, qualify, and program metrology platforms: tactile CMM (Zeiss), multi-sensor and vision (OGP, Keyence), surface metrology, optical and laser scanning.
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Execute MSA per AIAG: Gage R&R (crossed and nested), bias, linearity, stability, and attribute agreement analysis. Drive %GRR < 10% on critical features; remediate when out of tolerance.
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Manage gage control program: calibration intervals, recall, traceability, and fixturing standards.
SPC & Process Controls
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Establish SPC on CTQ characteristics with control charts fitted to the process. Set reaction plans tied to recognized run rules and enforce them at the operator level.
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Drive process capability to Cpk 1.33 minimum, Ppk 1.67 on safety and reliability characteristics, with documented capability studies pre-launch.
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Implement sampling per ANSI/ASQ Z1.4 and Z1.9; deploy c=0 plans where customer or regulatory regimes require.
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Stand up real-time data collection and shop-floor visualization tied to OEE and scrap metrics.
Nonconformance, CAPA & Continuous Improvement
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Disposition NCRs through MRB; lead containment, root cause analysis, and corrective action via 8D. Own the bridge from QRQC short-loop response to formal CAPA when systemic.
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Own CAPA effectiveness verification with statistical evidence; maintain recurrence rate below 5%.
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Serve as a direct contributor to continuous improvement: kaizen events, Gemba walks, A3 problem solving, DOE, mistake-proofing (poka-yoke), and SMED where quality-impacting.
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Drive cost-of-poor-quality reduction with quantified scrap, rework, and concession savings.
Customer Quality
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Conduct PPAP review, and host source inspection.
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Lead customer quality interface: source releases, deviation and concession requests, complaint investigations, and on-site audits.
Compliance
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Maintain QMS conformance to AS9100, ISO 13485, and the FDA QMSR (21 CFR Part 820). Support ITAR/EAR controls, DFARS flow-down, and EU MDR as program mix dictates.
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Maintain audit-ready posture for customers, registrar, and FDA.
Quality Management System
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Responsible for conforming with the company’s quality management system requirements, as well as contributing to its overall effectiveness and the ultimate goals of customer satisfaction, product compliance, and ethical practices.
REQUIRED EXPERIENCE / SKILLS / EDUCATION
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Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Materials Engineering. Equivalent technical discipline considered.
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5+ years in a precision CNC machining environment producing components with tolerances at or below ±0.0002 in (5 µm) and surface finishes 8 Ra µin. Direct exposure to Swiss turning, multi-axis milling, micro-machining, EDM, or grinding.
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Demonstrated work in regulated environments: AS9100, ISO 13485, FDA-regulated medical device manufacturing, or aerospace/defense prime supply chains.
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Direct floor-facing experience: Tier meeting cadence, QRQC deployment, operator coaching, and real-time line support.
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Fluency in GD&T per ASME Y14.5. Certification at Technologist or Senior level preferred.
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Documented MSA, Gage R&R, TMV, SPC, and capability study work product. Minitab or other statistical analysis proficiency.
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Command of PFMEA, Control Plans, FAI/PPAP, 8D, and CAPA.
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Six Sigma Black Belt advantageous
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Values treating people well, has an empathetic approach and mindset, is ambitious and strives for personal and collective excellence, supports diversity and inclusion, and has a positive outlook and attitude.
PREFERRED EXPERIENCE / SKILLS / EDUCATION
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Six Sigma Green Belt minimum; Black Belt preferred.
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ASQ CQE certification or equivalent demonstrated body of knowledge.
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Internal Auditor experience — AS9100 and/or ISO 13485.
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Experience with electronic QMS platforms and ERP-integrated quality modules (Infor LN).
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Nadcap special-process exposure: heat treat, NDT, chemical processing, or surface enhancement.
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Implant-grade or instrument-grade medical device manufacturing experience; or engine/structural aero component experience under AS13100.
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Reliability engineering exposure (Weibull, accelerated life testing).
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Direct experience in contract manufacturing or CDMO model serving multiple customer QMS regimes simultaneously.
Pay Range: $85,000 to $110,000 Base Annual Salary. The compensation for this role will be determined through our assessment process, taking into account your qualifications.
Note: While this position is primarily targeted at senior level, candidates with lesser experience may be considered.
What We’ll Offer You in Return:
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Base salary plus incentive program
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Paid time off (TOB, holidays, parental leave)
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Medical, dental, vision insurance
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Flexible Spending Account
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Health Savings Plan
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Life insurance, enhanced short term and long-term disability insurance and other voluntary insurance plans
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401k Profit sharing plan
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Tuition Reimbursement
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Employee Referral Bonus
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National Employee Assistance Program
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529 College Savings Program
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Professional development and training
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Brand new, modern workspace and manufacturing facilities
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Company events and outings, from Employee Appreciation Day to professional sports games
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Stable organization with opportunities for future growth within the company
About Precipart:
Precipart engineers, designs and manufactures high precision custom solutions for the world’s leading companies in the Medical, Aerospace and Industrial markets. We act as a partner across your entire manufacturing process by engineering precision gears, mechanical components, assemblies and motion control solutions, as well as delivering end-to-end capabilities and more. With offices in Switzerland, the U.S. and U.K, we are here to help you “engineer possible”.
