Quality Engineer I - Inspection and Project Management

Altus Spine•West Goshen Township, PA

10d•$65,000 - $72,000•Onsite

About The Position

Altus Spine is seeking a Quality Engineer I to perform hands-on dimensional inspection and lead CAPA investigations, root cause analysis, and cross-functional quality projects that support compliance and continuous improvement throughout the product lifecycle. The role is full-time and on-site in West Chester, Pennsylvania, with a stated salary range of $65,000–$72,000. The engineer conducts first article and first production lot inspections for new or changed part numbers, interpreting engineering drawings and checking dimensional requirements with calibrated equipment. The role also involves inspecting laser-etched markings, investigating recurring quality issues, owning CAPAs through closure, analyzing quality data, managing quality projects and records, coordinating internal audits, and supporting Management Review and applicable medical device quality system requirements.

Requirements

Bachelor's degree in Engineering or a technical field plus at least 2 years of experience; an Associate's degree plus at least 5 years; or a high school diploma plus at least 7 years of experience in a quality or engineering role within a regulated environment.
Experience owning CAPA investigations from initiation through effectiveness verification and closure.
Mechanical aptitude and hands-on physical measurement experience.
Experience managing cross-functional projects with defined scope, schedules, and deliverables.
Experience with root cause analysis, risk-based analysis, and quality systems within a regulated environment.
Working knowledge of medical device regulations, ISO standards, and quality management systems.
Ability to use calipers, micrometers, and mechanical inspection instrumentation.
Proficiency with Microsoft Office and experience with CAD software.
Valid driver's license.
Strong organizational skills and a detail-oriented, quality-focused approach.
Excellent communication and customer service skills, including the ability to conduct investigations with tact and professionalism.

Nice To Haves

Medical device experience is preferred.
RAM and Overlay experience is a plus.
Creo experience is preferred.
Experience with, or willingness to train and/or obtain, certifications related to ISO 13485, ISO 14971, cGMP, and other quality and regulatory systems supporting medical device compliance and safety.

Responsibilities

Perform first article and first production lot inspections for new and changed part numbers, interpreting engineering drawings and verifying dimensional requirements using calibrated inspection equipment.
Conduct hands-on dimensional inspections using calipers, micrometers, pin and thread gauges, optical comparators, and vision measurement systems.
Inspect laser-etched markings and small-font identification under magnification for accuracy and legibility.
Perform targeted inspections of parts with recurring quality issues and document findings to support root cause analysis and corrective actions.
Own CAPA investigations from initiation through root cause identification, corrective action implementation, effectiveness verification, and closure.
Analyze quality data to identify trends, lead cross-functional investigations, and drive corrective actions that prevent recurrence.
Manage quality projects, including remediation plans, validation activities, and quality system improvements, tracking deliverables and timelines.
Maintain CAPA and project tracking records, coordinate internal audits, and support Management Review and applicable medical device quality system requirements.

Benefits

Competitive salary of $65,000–$72,000.
Multiple health insurance plans, including a no-cost HSA health plan for eligible employees.
Affordable dental and vision benefits.
100% paid uniforms.
401(k) with employer match.
100 hours of PTO during the first year.
Work-Life Services Benefit Program for employees and family.
Group Life Insurance.
Seven paid holidays every year.
Paid training for certifications and licenses.
Wellness Coach Program access.