Quality Project Manager

Socket.dev; West Chester (Chester County); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Health plans (multiple)

HSA health plan (no-cost)

Dental & vision coverage

Uniforms provided

401(k) with employer match

PTO 100 hours first year

Work-Life Services Program

Life Insurance

Paid holidays

Training & certifications

Wellness program

Job summary

Altus Spine, a medical device innovator in West Chester, PA, is hiring a Quality Project Manager to lead CAPA investigations, root cause analysis, and cross-functional quality projects across the product lifecycle.

You will support inspection, compliance, and continuous improvement while coordinating audits and validation activities in a regulated environment.

Qualifications

• Experience owning CAPA investigations from initiation to closure.
• Experience managing cross-functional projects with defined scope and timelines.
• Working knowledge of medical device regulations and ISO standards.
• Ability to perform root cause analysis and risk-based analysis.

Responsibilities

• Own CAPA process from initiation to verification and closure.
• Lead cross-functional root cause investigations with input from Eng, Ops, Suppliers, and Customers.
• Establish verification methods and evidence for CAPA effectiveness.
• Maintain CAPA records, aging metrics, and escalation activities.
• Analyze complaints, nonconformities, returns and supplier data to identify trends.
• Lead quality projects including remediation plans and regulatory transitions.
• Maintain project trackers and provide summaries for Management Review.
• Coordinate internal audit program, scope and findings closure.
• Validate quality system software and maintain revalidation records.
• Perform first production lot inspections and support targeted inspections.
• Provide backup inspection during absences and surges.
• Support regulatory activities including 510(k) packaging and Management Review.

Skills

CAPA investigations

Root cause analysis

Cross-functional management

Documentation & records

Data analysis

Communication & teamwork

Attention to detail

Investigations leadership

Education

Bachelor's degree in Engineering

Associate's degree in technical field

High school diploma + 10+ years in quality/engineering

Tools

Creo

CAD software

Microsoft Office

Calipers & micrometers

RAM & Overlay experience

Job description

Now Hiring: Quality Project Manager

Full-Time| On-Site| West Chester,PA

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 Project Manager to lead CAPA investigations, root cause analysis, and cross-functional quality projects while supporting inspection, 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

• Own and manage the Corrective and Preventive Action (CAPA) process from initiation through effectiveness verification and closure.
• Lead structured root cause investigations, coordinating cross-functional input from Engineering, Operations, Suppliers, and Customers.
• Establish effectiveness verification methods and evidence requirements for CAPA activities and ensure effectiveness is demonstrated prior to closure.
• Maintain CAPA records, aging metrics, and escalation activities while presenting CAPA status, trends, and systemic themes to Quality Management.
• Analyze data from complaints, nonconformities, returns, supplier performance, and inspection results to identify trends and continuous improvement opportunities.
• Lead cross-functional quality projects involving remediation plans, validation activities, regulatory and standards transitions, and electronic quality management system changes.
• Maintain project trackers identifying project owners, deliverables, and due dates, and provide project summaries for Management Review.
• Coordinate the internal audit program, including audit scheduling, scope, auditor assignments, finding classification, and closure of findings.
• Coordinate validation of quality management system software applications and maintain revalidation records following configuration changes.
• Perform first production lot inspections for new and changed part numbers using calibrated inspection equipment and document results according to established procedures.
• Perform targeted inspections on parts with elevated nonconformance, complaint, or return rates to support data analysis and improvement initiatives.
• Provide backup inspection support during employee absences or production surges, including magnification inspection of small-font laser etching.
• Support quality and regulatory activities associated with product commercialization, including 510(k) submission packaging and Management Review.
• Apply working knowledge of applicable medical device regulations and standards, including ISO 13485:2016, 21 CFR Part 820, and ISO 14971:2019.

What You Bring

• 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. Medical device experience is preferred.
• Experience owning CAPA investigations from initiation through effectiveness verification and closure.
• 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 appropriate law. All employment is decided on the basis of qualifications, merit and business need.