Quality Assurance Specialist

2 weeks ago

Stoughton, Massachusetts, United States Boston Orthotics & Prosthetics Full time
OrthoPediatrics 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 orthotic and prosthetic services and products across the United States.

Our team upholds values of respectful truth and transparency in our interactions with patients, referral sources, and among ourselves. We are dedicated to delivering only the highest quality products and services to our patients. Our team is engaged and committed to the continuous enhancement of our offerings, patient care, and personal development.

JOB DESCRIPTION: Quality Assurance Engineer

GENERAL SUMMARY: The Quality Assurance Engineer will play a vital role in supporting the Orthopediatrics Specialty Bracing (OPSB) integrated quality management system across multiple sites. The ideal candidate will possess an entrepreneurial spirit with proven expertise in international regulatory compliance, quality system adherence, risk management, process enhancement, and change leadership. Strong communication skills and process implementation experience are essential.

This position is crucial in fostering growth and innovation for a high-performing global leader in pediatric medical device bracing. The role will assist in providing quality system leadership through risk management, document oversight, customer feedback handling, root cause analysis, corrective and preventive actions, and reduction of system waste and defects.

PERFORMANCE RESPONSIBILITIES:

Quality Management System:
  1. Support an ISO 13485 compliant medical device manufacturer focused on class 1/2 medical bracing solutions.
  2. Actively participate in New Product Development teams, contributing to risk management and post-market surveillance activities.
  3. Assist in post-market surveillance and risk management through data analytics, trend analysis, and key performance indicator monitoring.
  4. Summarize critical activities for medical device documentation development as directed by regulatory affairs.
  5. Oversee the Document Management System, including the review and revision cycles for standard operating procedures and other quality management documents.
  6. Facilitate small group discussions and work independently to maintain an effective quality management system through process improvement and data analysis.
  7. Support quality management system activities across multiple locations with cross-functional teams, promoting an integrated quality management culture.
Technical Communications: Support the development and revision of technical communications, including risk management and labeling requirements through collaboration with cross-functional teams.

Develop and revise Quality Management System documents, including manuals and standard operating procedures.

Change Management: Lead and mentor a culture that embraces necessary changes to sustain high product quality and create competitive advantages.

Compliance: Ensure company-wide adherence to medical device regulations including ISO 13485, ISO 14971, FDA, and EU MDR.

QUALIFICATIONS:
  • Demonstrated leadership and collaboration across multiple contributors and functional roles.
  • Proven competence in quality management system regulation and compliance within a fast-paced business environment.
  • Advanced knowledge and skills to maintain compliance with best-in-class processes for Class 1/2 medical devices.
  • Experience in risk management, document oversight, process improvement, and change leadership.
  • Education and experience necessary to effectively lead teams in the specified areas of responsibility.
  • Proven ability to manage high-performance teams to achieve goals on time and within budget.
  • Core skills in quality management systems including facilitation, root cause analysis, risk management, and data analytics.
Other Skills, Abilities, and Requirements:
  • Proactive and self-motivated; capable of contributing to teams and working independently.
  • Hands-on approach, involved at all levels, capable of leading teams while also executing tasks.
  • Ability to coach, mentor, and train others in areas of responsibility.
  • Support internal and external audits and other stakeholder needs.
  • Experience with Lean/Six Sigma methodology is preferred.
  • Strong problem-solving skills and creativity.
  • Provide support across multiple sites, with some travel expected.
  • Understanding of the orthopedic industry and the company’s markets is preferred.
  • 4-year degree in Engineering, Business, Healthcare, or a related field.
  • Minimum of 3 years of experience in the medical device sector.
  • Experience with FDA 510(k) submissions.
  • Advanced knowledge of ISO 13485, ISO 14971, and global regulations.
  • Experience in Orthotics & Prosthetics (O&P) is preferred.
WORKING CONDITIONS:

Office and manufacturing environments

Travel to multiple sites

PHYSICAL DEMANDS:
  • Limited warehouse and manufacturing process activities.
  • Occasional light lifting up to 25 pounds.
Equal Opportunity Employer:

Boston O&P is committed to fostering a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or veteran status, in accordance with applicable laws.

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