Quality Engineer I - Inspection and Project Management

Now Hiring: Quality Engineer I - Inspection and Project Management

Grow Your Career with Outstanding Employee Benefits!

Full-Time| On-Site| West Chester, PA | Salary $65,000–$72,000

Join Altus Spine

At Altus Spine, 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 I – Inspection & Project Management to perform hands-on dimensional inspection and lead CAPA investigations, root cause analysis, and cross-functional quality projects that drive compliance and continuous improvement across the product lifecycle.

What We Offer

• 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

Your Impact

• 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.

What You Bring (Qualifications)

• Bachelor's degree in Engineering or a technical field plus 2+ years of experience ; Associate's degree plus 5+ years ; or High School diploma plus 7+ years of experience in a quality or engineering role within a regulated environment. Medical device experience is preferred.
• 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. RAM and Overlay experience is a plus.
• 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.

Altus Spine is proud to be an Equal Opportunity Employer. Altus Spine does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any basis covered by applicable law. All employment is decided on the basis of qualifications, merit and business need.

*Principals only. Recruiters please do not apply on behalf of your candidates to Altus Spine job posts. All applications and/or contact information submitted are kept on file and are the property of Altus Spine. Please note recruiting fees will not be honored with candidate applications submitted by recruiters.