- 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.
- 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.
- Limited warehouse and manufacturing process activities
- Occasional light lifting to 25 pounds
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Quality Assurance Engineer - Stoughton, United States - Boston Orthotics & Prosthetics
Description
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 KIDSOur 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 -
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:
Office and manufacturing
Travel; multiple sites
PHYSICAL DEMANDS:
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.
The above statement reflects the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.
