Quality Assurance Engineer jobs in Massachusetts
Quality Assurance Engineer performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products. Assists in developing quality control policies and evaluates production limitations. Being a Quality Assurance Engineer requires a bachelor's degree. Typically reports to a supervisor or manager. To be a Quality Assurance Engineer typically requires 0-2 years of related experience. Works on projects/matters of limited complexity in a support role. Work is closely managed. (Copyright 2024 Salary.com)
Recently Added Quality Assurance Engineer jobs
Quality Assurance Engineer
- Boston Orthotics & Prosthetics
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Stoughton, MA
FULL_TIME
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OrthoPediatrics Specialty Brace: As a leader in specialized pediatric orthotics, we take great pride in having the industry's top clinicians, technicians, and administrative staff, led by an executive team dedicated to advancing the orthotics and prosthetics profession. We have recently joined forces with OrthoPediatrics as their Specialty Bracing division to help more KIDS!
Our Vision: To be recognized as the premier provider of pediatric orthotic and prosthetic services and products in the United States.
Our team believes in respectful truth and transparency when interacting with patients, referral sources, and our own team members. We hold ourselves accountable for providing only the best products and services to our patients. Our team is engaged and committed to continuous improvement of our products, our patient care, and ourselves.
JOB DESCRIPTION: Quality Assurance Engineer
GENERAL SUMMARY: The Quality Assurance Engineer will support the Orthopediatrics Specialty Bracing (OPSB) multisite integrated quality management system. The ideal candidate will be an entrepreneur with proven experience in international regulatory and quality system compliance, risk management, process improvement, and change leadership. Strong skills in communications and process deployment.
This is a key role in supporting the goals of growth and innovation for a high performing global leader in our niche of pediatric medical device bracing. This position will support the team in providing quality system leadership through risk management, document management, customer feedback & complaint handling, root cause analysis, corrective and preventative action, and system waste & defect reduction.
Performance Responsibilities
Quality Management System -- Responsible for supporting an ISO 13485 compliant medical device manufacturer; class 1/ 2 medical bracing solutions.
- Active member of New Product Development teams; supporting development of risk management and post market surveillance activities/ plans.
- Support post market surveillance and risk management activities through data analytics, trend analysis, key performance indicator monitoring and reporting.
- Summarize Risk Management and other critical activities for medical device documentation development as guided by regulatory affairs.
- Manage the Document Management System, including review and revision cycles for standard operating procedures, and other quality management system documents and records.
- Facilitate small groups and work independently as assigned to support the maintenance of an effective, suitable, and adequate quality management system though, process improvement, waste reduction, quality plan achievement, root cause analysis, corrective and preventative actions, and data analysis.
- Provide support for quality management system activities in multiple site locations with cross functional teams, supporting an integrated quality management system culture and structure.
Development and revision of Quality Management System documents including but not limited to; manuals, standard operating procedures, and work instructions.
Change Management – Lead, coach, and mentor a culture which embraces the changes required to sustain the highest product quality, lowest cost structure, and creating competitive advantages.
Compliance - Support company-wide medical device compliance with ISO 13485, ISO 14971, FDA, EU MDR, Health Canada, and rest of world.
Qualifications- Demonstrated cross-functional leadership and collaboration with multiple contributors, locations, and functional roles.
- Demonstrated competence in quality management system regulation and compliance, business process, core skills and capabilities within a high performing and fast paced business culture.
- Advanced level of knowledge and skills required to work effectively, maintain compliance with best-in-class process discipline for Class 1/ 2 medical devices.
- Experience demonstrating proven success in risk management, document management, process improvement, and change leadership.
- Education, demonstrated skills, and experiences required to effectively lead teams in areas of responsibility defined above.
- Proven ability to manage high-performance teams in the execution of plans for on time and within budget goal achievement.
- Core quality management system skills including but not limited to: culture of inclusion, facilitation, root cause analysis, risk management, document development and management, data analytics and reporting, project management, training, and leading change.
- Proactive and self-starting; ability to be a strong contributor to teams and work independently.
- Hands on approach, highly involved from top to bottom, capable of leading teams as well as “doing”. Promotes culture of inclusivity and value for team member collaboration.
- The ability to coach, mentor, and train the organization in areas of responsibility.
- Support internal and external audits and other ad hoc stakeholder needs.
- Experience with and preferred background in Lean/ Six Sigma methodology.
- Problem-solving skills, creativity, with a strong curiosity
- Provide site support for multiple sites, some travel is expected at routine intervals.
- Understanding of O&P business environment, the orthopedic industry, and the company’s markets is preferred Education and/or Experience.
- 4-year degree; in Engineering, Business, Heathcare, or equivalent background and experience.
- Minimum 3 years medical device experience.
- Experience with FDA 510(k) submission
- Advanced experience with ISO 13485, ISO 14971, and world regulation
- Orthotics & Prosthetics (O&P) experience preferred.
Office and manufacturing
Travel; multiple sites
Physical Demands- Limited warehouse and manufacturing process activities
- Occasional light lifting to 25 pounds
Boston O&P is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. - 2 Days Ago
Quality Assurance Engineer II
- Robert Half
-
Bedford, MA
CONTRACTOR
- DescriptionOnly candidates in or near the Bedford, Massachusetts will be considered for this onsite role. We are in the process of hiring a Quality Assurance Analyst based in Bedford, Massachusetts. T...
- 3 Days Ago
Test/Quality Assurance Engineer
- Odyssey Systems Consulting Group, Ltd.
-
Massachusetts, MA
FULL_TIME
- Position SummaryOdyssey Systems has a thrilling new Maritime Domain Awareness project that requires a dynamic team of engineers to design, build, test, and deliver security and surveillance vehicles a...
- 3 Days Ago
Quality Assurance Engineer
- Umanist Staffing
-
Ayer, MA
FULL_TIME
- Quality Control Professional OpportunityPosition SummaryIn this role, you will be responsible for developing, modifying, applying, and maintaining quality standards for products and processes. You wil...
- 4 Days Ago
Quality Assurance Engineer
- DPS Group Global
-
Framingham, MA
FULL_TIME
- SummaryDPS Engineering is looking for a Quality Assurance Specialist .The candidate will provide quality oversight and expertise to enable technical success with stringent adherence to a Quality Syste...
- 5 Days Ago
Quality Assurance (QA) Engineer
- Lazarus AI
-
Cambridge, MA
FULL_TIME
- Lazarus AI creates dynamic, highly accurate machine learning APIs to solve the data extraction and data activation challenges of our customers. Our latest innovation, RikAI, is a large language model ...
- 6 Days Ago
Quality Assurance Engineer jobs at Popular Companies
Quality Assurance Engineer
- iApartments
-
Tampa, FL
- iApartments is looking for a passionate and detail-oriented QA Engineer to help build our cloud-based solutions in the m...
- 6/10/2024 12:00:00 AM
Quality Assurance Engineer
- Motion Recruitment
-
San Francisco, CA
- Job Description - QA Engineer: • Work with product managers and developers and come up with a proper test plan, test sce...
- 6/10/2024 12:00:00 AM
Quality Assurance Engineer
- 5V Video | Certified B Corp™
-
Philadelphia, PA
- 👨💻 Wi-FI QA Engineer 🏢 Philadelphia, PA 🏡 Hybrid: 3 days on-site 📄 Rolling 6-month contracts on W2 / Project lengt...
- 6/9/2024 12:00:00 AM
Quality Assurance Engineer
- Insight Global
-
Berkeley Heights, NJ
- Position: QA Engineer Location: Omaha, NE or Berkley Heights, NJ - 5 days a week onsite Duration: 12 Month Contract to D...
- 6/9/2024 12:00:00 AM
Quality Assurance Engineer
- Compunnel Inc.
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Westbrook, ME
- Description Are you a QA Engineer with solid automation skills able to build upon existing frameworks? Our client is loo...
- 6/8/2024 12:00:00 AM
Quality Assurance Engineer
- OSTechnical
-
- Job Description: Mobile App QA Engineer Overview: We are seeking a meticulous and dedicated Mobile App QA Engineer to jo...
- 6/8/2024 12:00:00 AM
Quality Assurance Engineer
- Motion Recruitment
-
- Our client, a legal analytics company, is looking for a QA Engineer to join their team on a 12 month contract that can p...
- 6/8/2024 12:00:00 AM
Quality Assurance Engineer
- Arrow International, Inc
-
Henderson, NV
- Job Type Full-time Description Arrow International is the world's largest manufacturer and supplier of charitable gaming...
- 6/7/2024 12:00:00 AM
About Massachusetts
Massachusetts is the 7th-smallest state in the United States. It is located in the New England region of the northeastern United States and has an area of 10,555 square miles (27,340 km2), 25.7% of which is water. Several large bays distinctly shape its coast. Boston is the largest city, at the inmost point of Massachusetts Bay, and the mouth of the Charles River.
Despite its small size, Massachusetts features numerous topographically distinctive regions. The large coastal plain of the Atlantic Ocean in the eastern section of the state contains Greater Boston, along with most of the state's po...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Engineer jobs
$73,336 to $91,032
Most Popular Cities in Massachusetts for Quality Assurance Engineer Jobs
What does a Quality Assurance Engineer do?
Quality Assurance Engineer in Albany, GA
Quality assurance engineers report to the director of engineering and have the primary responsibility of developing and maintaining production quality standards.
November 09, 2019
Quality Assurance Engineer in Huntington, WV
Principal Engineers are recognized as an emerging expert.
November 29, 2019
Quality Assurance Engineer in Nassau, NY
You’ll be supporting a team of over thirty engineers, delivering value to millions, while having fun in a diverse and rewarding environment.
December 19, 2019
Quality Assurance Engineer Job Description, Duties, and Responsibilities.
November 30, 2019