New · posted Oct 15
Globus Medical · Medical Devices
Director, Quality
- Audubon, PA
- On-site
- Full-time
- Director
Open until filled
The role
The Director of Quality provides strategic leadership and oversight of the company’s global quality systems, with direct responsibility for Quality Engineering at the Audubon (HQ) site, International Operations Quality, and Sterile Manufacturing Quality. This position ensures compliance with applicable regulatory requirements (FDA QSR, ISO 13485, EU MDR, MDSAP, etc.) and alignment with company objectives for product safety, effectiveness, and continuous improvement. The Director will collaborate cross-functionally with Manufacturing, Supply Chain, R&D, and Regulatory teams to maintain a culture of quality excellence and operational efficiency across all facilities and international markets.
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.
What you need
Minimum BS degree or equivalent in Science or Engineering. A relevant post-graduate qualification would be an advantage but not essential
Minimum of 5 years of experience is needed within Medical Device Quality Assurance/ Quality Systems with experience in FDA and CE Notified Body inspections
Experience in product quality assurance, process quality, verification and validation
Experience with electro-mechanical medical devices, including software, is desired
ASQ Certification or equivalent formal training and experience is desired. Multi-discipline assurance background is desired. Knowledge of Lean Manufacturing, Six Sigma, and reliability engineering is a plus
Demonstrated knowledge and understanding of the Quality System Regulations (FDA) and standards, ISO 13485, and other related regulations with emphasis in problem solving and CAPA Systems
Computer proficiency with MS Office and statistical analysis tools is required; Must be able to make solid decisions that effectively support the business and company policies
Presentation skills and ability to train personnel in quality matters
Travel requirements are as needed
What you'll do
Leadership & Strategy
Develop and execute the global quality strategy aligned with company objectives and regulatory requirements.
Provide leadership, mentoring, and development for the Quality Engineering, International Quality, and Sterile Manufacturing Quality teams.
Serve as a senior quality representative in management review, audits, and regulatory inspections.
Drive a culture of accountability, continuous improvement, and proactive risk management.
Quality Engineering
Oversee product quality engineering, including design assurance, process validation, risk management, and post-market feedback.
Ensure robust CAPA, complaint handling, and nonconformance processes.
Lead validation strategy and ensure compliance with ISO 14971, ISO 13485, and 21 CFR Part 820 requirements.
Support new product development and design transfer to manufacturing.
International Operations Quality
Oversee quality system compliance at all international manufacturing and distribution sites.
Ensure adherence to global regulatory requirements including MDSAP, EU MDR, Health Canada, PMDA, and TGA.
Harmonize global quality processes and drive consistency across regions.
Support international audits and coordinate responses to regulatory authorities.
Sterile Manufacturing Quality
Provide oversight of sterilization validation, monitoring, and requalification programs in accordance with ISO 11135 / ISO 11137 / ISO 17665.
Ensure control of cleanroom operations, environmental monitoring, aseptic techniques, and contamination control programs.
Approve sterilization cycles, validations, and deviations.
Support product release and ensure compliance with sterility assurance requirements.
Audits, Compliance & Continuous Improvement
Lead or support internal and external quality audits.
Ensure timely closure of audit findings and CAPA actions.
Implement continuous improvement initiatives to enhance quality system performance and product reliability.
Monitor and report key quality metrics to executive management.
Where you'll work
Audubon, PAOn-siteOpen in Maps (opens in a new tab)
More jobs in Audubon, PAWorking conditions
The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.
Required to sit; climb or balance; and stoop, kneel, crouch or crawl
Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
From the posting
About Globus Medical
Our Values
Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.
Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.
Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal opportunity, accessibility and legal noticesGlobus Medical's statements, word for word
Equal Employment Opportunity
Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
Director roles in Pennsylvania5 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| Pennsylvania (middle half) | $216,000 | $223,000 | $226,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Globus Medical's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance11
- Quality systems and risk11
- Collaboration and leadership8
- Validation and qualification6
- Investigations and CAPA4
- Regulatory submissions2
- Data and digital systems2
- Documentation and SOPs1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
Globus Medical on Regulatory Jobs
- 11
- Open roles
- 10
- Distinct roles
- 4
- Locations
By discipline
- Quality7 64%
- Regulatory4 36%
By level
- Associate & Specialist9 82%
- Director1 9%
- Senior & Principal1 9%
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Director, Quality at Globus Medical
Open until filled.