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Qms Jobs in Boston, MA (NOW HIRING)

SharkNinja

QMS Program Manager

Needham, MA · On-site

QMS Program Manager, Medical Devices Needham, MA, United States As the QMS Program Manager, Medical Devices, you will own the general oversight and performance tracking of SharkNinja's Quality ...

SharkNinja

QMS Program Manager

Needham, MA · On-site

QMS Program Manager, Medical Devices Needham, MA, United States As the QMS Program Manager, Medical Devices, you will own the general oversight and performance tracking of SharkNinja's Quality ...

Ninjakitchen

QMS Program Manager

Needham, MA · On-site

$107 - $150/hr

QMS Program Manager, Medical Devices Needham, MA, United States As the QMS Program Manager, Medical Devices, you will own the general oversight and performance tracking of SharkNinja's Quality ...

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Ardelyx

Executive Director, QMS & Digital

Waltham, MA · Hybrid

$252K - $308K/yr

The Executive Director, QMS and Digital is a senior leader within the Quality organization, reporting to the SVP, Head of Quality. This role is accountable for the strategy, governance, effectiveness ...

Ardelyx

Executive Director, QMS & Digital

Waltham, MA · Hybrid

$252K - $308K/yr

The Executive Director, QMS and Digital is a senior leader within the Quality organization, reporting to the SVP, Head of Quality. This role is accountable for the strategy, governance, effectiveness ...

Ardelyx

Executive Director, QMS & Digital

Waltham, MA · Hybrid

The Executive Director, QMS and Digital is a senior leader within the Quality organization, reporting to the SVP, Head of Quality. This role is accountable for the strategy, governance, effectiveness ...

Ardelyx

Executive Director, QMS & Digital

Waltham, MA · On-site

$252K - $308K/yr

The Executive Director, QMS and Digital is a senior leader within the Quality organization, reporting to the SVP, Head of Quality. This role is accountable for the strategy, governance, effectiveness ...

Ardelyx

Executive Director, QMS & Digital

Waltham, MA · On-site

$252K - $308K/yr

The Executive Director, QMS and Digital is a senior leader within the Quality organization, reporting to the SVP, Head of Quality. This role is accountable for the strategy, governance, effectiveness ...

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Qms information

What does a QMS professional do?

QMS professionals are experts who manage and implement Quality Management Systems within organizations. Their main role is to ensure that a company’s products or services consistently meet customer and regulatory requirements by developing, maintaining, and improving quality policies and procedures. They conduct audits, facilitate compliance with standards like ISO 9001, and drive continuous improvement initiatives. QMS professionals work across industries such as manufacturing, healthcare, and services to help organizations achieve high standards of quality and efficiency.

What skills and qualifications are needed to thrive as a QMS professional?

To thrive as a Quality Management System (QMS) Specialist, you need a solid understanding of quality standards (such as ISO 9001), process improvement methodologies, and experience with audits, often supported by a degree in engineering or a related field. Familiarity with QMS software platforms, document control systems, and relevant certifications like ISO 9001 Lead Auditor or Six Sigma is typically required. Strong attention to detail, analytical thinking, and effective communication are vital soft skills for ensuring compliance and driving quality initiatives. These skills and qualifications are important because they help organizations maintain regulatory compliance, improve efficiency, and deliver high-quality products or services.

What are common challenges faced by QMS professionals, and how can they be managed?

Professionals in QMS roles often encounter challenges such as ensuring consistent compliance with changing industry regulations, promoting a culture of quality across diverse teams, and managing documentation efficiently. Effective communication and regular training are vital for keeping teams aligned with quality standards. Additionally, implementing robust digital tools for document control and ongoing audits can streamline processes and make regulatory compliance more manageable. Collaboration with cross-functional teams is key to identifying improvement opportunities and resolving quality issues promptly.

What is the difference between Qms vs Quality Assurance Specialist?

AspectQmsQuality Assurance Specialist
CertificationsISO 9001 Lead Auditor, Quality Management certificationsISO 9001, Six Sigma, CQE
Work EnvironmentManufacturing, industrial, or service sectors focusing on quality systemsManufacturing, software, healthcare, and various industries
Employer & Industry UsageOrganizations implementing quality management systemsCompanies ensuring product/service quality
Search & Comparison IntentUnderstanding quality system implementationQuality process evaluation and improvement

Qms professionals focus on establishing, maintaining, and auditing quality management systems within organizations, often working with standards like ISO 9001. Quality Assurance Specialists concentrate on testing, inspection, and ensuring products or services meet quality standards. While both roles aim to improve quality, Qms roles are more system-oriented, whereas Quality Assurance Specialists are more product-focused.

How to become a QMS engineer?

To become a QMS (Quality Management System) engineer, candidates typically need a bachelor's degree in engineering, quality assurance, or a related field. Gaining experience in quality control, understanding ISO 9001 standards, and obtaining certifications like ASQ Certified Quality Engineer can enhance prospects. Strong analytical skills and familiarity with quality management tools are also important.

What are the most commonly searched types of Qms jobs in Boston, MA?

The most popular types of Qms jobs in Boston, MA are:

What are popular job titles related to Qms jobs in Boston, MA?

For Qms jobs in Boston, MA, the most frequently searched job titles are:

What job categories do people searching Qms jobs in Boston, MA look for?

The top searched job categories for Qms jobs in Boston, MA are:

What cities near Boston, MA are hiring for Qms jobs?

Cities near Boston, MA with the most Qms job openings:

Qms jobs near you
Infographic showing various Qms job openings in Boston, MA as of August 2026, with employment types broken down into 100% Full Time. Highlights an 100% In-person job distribution.

QMS Program Manager

SharkNinja

Needham, MA • On-site

Full-time

Posted 27 days ago

SharkNinja rating

8.2

Company rating: 8.2 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

47th of 161 rated electronics manufacturers

Job description

QMS Program Manager, Medical Devices 

Needham, MA, United States 

As the QMS Program Manager, Medical Devices, you will own the general oversight and performance tracking of SharkNinja's Quality Management System (QMS) as it applies to medical devices and guide New Product Development (NPD) teams across Skincare and Wellness in developing safe and effective devices. This role ensures quality and safety are designed into products from concept through post-market-while enabling SharkNinja's fast-paced, consumer-driven product development model. 

Partnering closely with Product Integrity, Product Development, Engineering, PMO, Compliance, Legal Supply Chain, and Commercial teams, you will translate quality strategy into execution, support the geographic expansion of the medical devices' portfolio, and lead post-market surveillance activities-ensuring quality is embedded into the product lifecycle, not inspected in after the fact. 

Key Responsibilities 

QMS Oversight & Performance Tracking 

  • Provide general oversight of SharkNinja's Quality Management System for medical devices, ensuring it remains effective, audit-ready, and aligned with applicable standards (e.g., ISO 13485, FDA 21 CFR Part 820 / QMSR). 
  • Track and report QMS performance through clear KPIs, dashboards, and management reviews, driving accountability and continuous improvement across the organization. 

NPD Guidance - Safe & Effective Devices 

  • Guide New Product Development (NPD) teams across Skincare and Medical Devices in developing safe and effective devices, embedding design controls, risk management (ISO 14971), and verification and validation into the development process. 
  • Translate quality and safety requirements into clear, digestible, execution-ready guidance for Product Development and Engineering teams. 

Cross-Functional Collaboration 

  • Partner with cross-functional teams to build safe and effective medical devices, serving as a voice of Medical Device Compliance and Consumer in design reviews, product development, and change-management forums. 
  • Influence senior stakeholders to align on quality priorities, trade-offs, and risk-mitigation strategies. 

Geographic Expansion 

  • Support the geographic expansion of the medical devices portfolio, ensuring QMS processes and product documentation meet regional quality and regulatory expectations in new and emerging markets. 

Post-Market Surveillance & Change Management 

  • Support Engineering Change Notices (ECNs), including impact assessment and documentation, to maintain compliance and product performance across the product lifecycle. 

Qualifications & Experience 

Required 

  • Bachelor's or master's degree in engineering, Life Sciences, Quality, or a related technical discipline. 
  • 7-10+ years of experience in quality, QMS, or program management, preferably within medical devices, electromechanical devices, or regulated consumer product environments. 
  • Working knowledge of medical device quality requirements, including ISO 13485, ISO 14971, FDA 21 CFR Part 820 / QMSR, design controls, CAPA, and post-market surveillance. 
  • Demonstrated ability to lead complex, cross-functional programs and partner effectively across R&D, Engineering, Regulatory, Quality, and Commercial teams in matrixed organizations. 
  • Strong communication skills with the ability to translate quality and regulatory complexity into practical product and engineering guidance. 

Preferred 

  • Experience enabling compliant innovation in fast-paced, high-velocity consumer product environments. 
  • Experience supporting global market expansion and product registrations for medical devices. 

Key Competencies 

  • Strategic thinker with strong execution discipline. 
  • Data-driven problem solver with a pragmatic, risk-based mindset. 
  • Comfortable operating in ambiguity and fast-paced environments. 
  • Collaborative, credible leader with strong business judgment and a consumer-first mindset. 

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