Quality Engineer I - Inspection and Project Management

Altus Spine•West Goshen Township, PA

1d•$65,000 - $72,000•Onsite

About The Position

Join Altus Spine where we develop innovative spinal implant and surgical solutions where quality, precision, and patient safety are at the center of what we do. We are seeking a Quality Engineer - Inspection & Project Management to support hands-on inspections, lead CAPA investigations, root cause analysis, and cross-functional quality projects while ensuring compliance, and continuous improvement across the product lifecycle.

Requirements

Bachelor's degree in Engineering or a technical field plus 5+ years of experience; Associate's degree plus 7+ years; or High School diploma plus 10+ 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; Creo 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.
Valid driver's license.
Strong organizational skills with a detail-oriented and quality-focused approach.
Excellent communication and customer service skills, with the ability to conduct investigations with tact and professionalism.

Nice To Haves

Medical device experience is preferred.
RAM and Overlay experience is a plus.

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 to verify accuracy and legibility.
Perform targeted inspections of parts with recurring quality issues, documenting 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
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 your first year
Work-Life Services Benefit Program (Employee + Family)
Group Life Insurance
Seven paid holidays every year
Investing in you: paid training for certifications and licenses
Wellness Coach Program access