Quality Assurance Engineer
3 weeks ago
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.
Technical Communications– Support technical communication development and/ or revision including but not limited to; risk management, post market surveillance, and labeling requirements with cross function team collaboration.
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
Equal Opportunity Employer
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.
-
Quality Assurance Specialist
2 weeks ago
Stoughton, Massachusetts, United States Boston Orthotics & Prosthetics Full timeOrthoPediatrics Specialty Brace: At Boston Orthotics & Prosthetics, we pride ourselves on being leaders in specialized pediatric orthotics, supported by a team of top clinicians, technicians, and administrative staff, guided by an executive team committed to enhancing the orthotics and prosthetics field. Our Vision: To be acknowledged as the foremost...
-
Quality Assurance Specialist
2 weeks ago
Stoughton, Massachusetts, United States Boston Orthotics & Prosthetics Full timeOrthoPediatrics Specialty Brace: As a prominent entity in specialized pediatric orthotics, we take immense pride in having the industry's leading clinicians, technicians, and administrative personnel, guided by an executive team committed to enhancing the orthotics and prosthetics field. Our Vision: To be acknowledged as the foremost provider of pediatric...
-
Quality Assurance Manager
5 days ago
Stoughton, United States Employbridge Full timeWe are seeking a highly skilled and dedicated Quality Assurance Manager to join our team in the food production industry. As a Quality Assurance Manager, you will play a crucial role in ensuring that our products meet and exceed industry standards for safety, quality, and consistency. You will be responsible for developing and implementing quality management...
-
Quality Assurance Manager
6 days ago
Stoughton, United States Employbridge Full timeWe are seeking a highly skilled and dedicated Quality Assurance Manager to join our team in the food production industry. As a Quality Assurance Manager, you will play a crucial role in ensuring that our products meet and exceed industry standards for safety, quality, and consistency. You will be responsible for developing and implementing quality management...
-
Quality Assurance Specialist
7 days ago
Stoughton, Wisconsin, United States Compunnel Inc. Full timeJob SummaryWe are seeking a detail-oriented and experienced Quality Assurance Specialist to join our team at Compunnel Inc. as a Quality Control Technician.About the RoleThe ideal candidate will be responsible for conducting quality control inspections to ensure compliance with FDA regulations, ISO 9001. The Inspector of Quality will be responsible for...
-
Quality Assurance Specialist
3 days ago
Stoughton, Wisconsin, United States Eastridge Workforce Solutions Full timeJob SummaryEastridge Workforce Solutions is a leading provider of workforce management solutions, committed to connecting skilled professionals with meaningful career opportunities. We are seeking a detail-oriented and experienced Quality Technician to join our team.Key ResponsibilitiesConduct quality control inspections of products and materials to ensure...
-
Inspector of Quality
7 days ago
Stoughton, Wisconsin, United States Compunnel Inc. Full timeJob SummaryWe are seeking a detail-oriented and experienced Quality Control Specialist to join our team at Compunnel Inc. as a Quality Assurance Specialist.Key ResponsibilitiesConduct quality control inspections of products and materials to ensure compliance with FDA regulations and industry standards.Fabricate and assemble products in accordance with design...
-
Manufacturing Quality Control Manager
7 days ago
Stoughton, Wisconsin, United States Compunnel Inc. Full timeJob SummaryWe are seeking a detail-oriented and experienced Quality Assurance Specialist to join our team at Compunnel Inc. as a Quality Control Technician.Key ResponsibilitiesConduct thorough quality control inspections of products and materials to ensure compliance with FDA regulations and industry standards.Fabricate and assemble products in accordance...
-
2nd Shift Quality Control Inspector
6 days ago
Stoughton, United States The HEICO Companies, LLC Full timeAre you looking for an opportunity to move your career forward with an established industry leader? Join our team at Zalk Josephs Fabricators! Zalk Josephs Fabricators has been in the structural steel fabrication business for over a century and supplies structural steel across the Midwest. The Zalk Josephs team has built their reputation on proven...
-
Application Engineer
2 weeks ago
Stoughton, United States Craft Recruiting Full timeWe are a leading global company specializing in engineering, manufacturing, and distributing innovative solutions in Air & Fluid Transfer, NVH, Complex Structural, Acoustic, and Thermal Management. We partner with world-renowned OEMs to deliver high-quality, cost-effective solutions that meet customer needs and environmental standards. We are seeking a Sales...
-
Application Engineer
2 weeks ago
Stoughton, United States Craft Recruiting Full timeWe are a leading global company specializing in engineering, manufacturing, and distributing innovative solutions in Air & Fluid Transfer, NVH, Complex Structural, Acoustic, and Thermal Management. We partner with world-renowned OEMs to deliver high-quality, cost-effective solutions that meet customer needs and environmental standards. We are seeking a Sales...
-
Senior Design Engineer
21 hours ago
Stoughton, Massachusetts, United States Amphenol Alden Products Company Full timeJob Description**About Amphenol Alden Products Company**We are a leading manufacturer of interconnect and cable assembly products for the medical technology industry. Our company is committed to delivering innovative solutions that transform healthcare and improve lives.**Job Summary:**We are seeking a highly skilled Design Engineer II to join our dynamic...
-
Principal Electrical Engineer
1 month ago
Stoughton, Wisconsin, United States Spherion Full timeDirect hireBenefits package$120-130K + BonusHow often do you come across the opportunity to work with a company with a unique product produced nowhere else in America? You just did Our client is the global leader in manufacturing their product category and with a values-driven culture and commitment to continual improvement, they can deliver exceptional...
-
Design Engineer II
4 days ago
Stoughton, United States Amphenol Alden Products Company Full timeJob DescriptionJob DescriptionJoin us to help save lives!Are you ready to make a significant impact in the medical technology industry? We are looking for a Design Engineer II to join our dynamic and expanding design engineering team. In this role, you will be an integral part of our project-specific cross-functional teams, collaborating closely with both...
-
Design Engineer II
1 day ago
Stoughton, United States Amphenol Alden Products Company Full timeJob DescriptionJob DescriptionJoin us to help save lives!Are you ready to make a significant impact in the medical technology industry? We are looking for a Design Engineer II to join our dynamic and expanding design engineering team. In this role, you will be an integral part of our project-specific cross-functional teams, collaborating closely with both...
-
Industrial Designer
1 day ago
Stoughton, United States AQUA-LEISURE RECREATION LLC Full timeJob DescriptionJob DescriptionDescription:Aqua-Leisure Recreation, LLC is a branded consumer products company serving the needs and aspirations of millions of consumers in the market for leisure and sport related aquatic and winter products. We serve customers on a worldwide basis through a variety of sales channels including sporting goods dealers, mass...
-
Director of Contract Manufacturing Sales
2 weeks ago
Stoughton, United States Avon Food Company Full timeWe are seeking a dynamic and experienced Director of Contract Manufacturing Sales to lead our efforts in expanding and managing client relationships within the liquid food manufacturing sector. In this role, you will be responsible for driving revenue growth, developing strategic partnerships, and ensuring exceptional service delivery. Key...
-
Manager - Environmental Health & Safety
3 months ago
Stoughton, United States Stoughton Trailers Full timeJob Purpose Provide support and leadership to plant operations management through the implementation of environmental, health and safety programs, procedures, and education initiatives focused on continuous improvement, compliance assurance, incident reduction, and risk mitigation. Essential Duties and Responsibilities Support overall business strategy by...
-
Pharmaceutical Production Operator
2 weeks ago
Stoughton, Wisconsin, United States ExpressPros - Madison Full timeJob OverviewAre you dedicated to excellence, quality assurance, and contributing to the pharmaceutical sector? ExpressPros - Madison is currently in search of a Pharmaceutical Process Operator to become an integral part of our team.Compensation: $18-20/hour; potential for increase after performance reviewWork Schedule: Monday to Friday, 2pm-10:30pm**Initial...
-
Stoughton, United States FLOURISHING HOME CARE LLC Full timeJob Summary: Performing a variety of Human Resource tasks, clerical tasks, office support, reception tasks, and other related tasks as required Develops and monitors plans of care for home and community-based clients and ensures consistent provision of quality services in keeping with client goals and objectives, agency philosophy, policies, and program...