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About the Role

OP Specialty Bracing is growing and seeking a motivated Quality Assurance Engineer to support the international integrated quality management system. This role is key to business optimization and sustainment for a global leader in pediatric medical device bracing, supporting integration with newly acquired sites in the United Kingdom.

Responsibilities

Support an ISO 13485:2016 compliant medical device manufacturer.
Lead Business Optimization & Sustainment Quality Pillar.
Support implementation of business integration activities.
Conduct supplier, contract manufacturer, and distributor internal audits.
Develop and execute validation plans for software, manufacturing facilities, and equipment.
Summarize critical activities for quality management system integration, monitoring, and optimization.
Facilitate small groups and work independently to support the maintenance of an effective quality management system through 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.
Perform all other duties as assigned by manager.
Support technical communication development and/or revision including software, equipment, and facilities IQ/OQ/PQ-validation plans, value stream maps, audit assessments and reports, supplier/distributor corrective action planning, and system waste reduction planning.
Develop and revise Quality Management System documents including manuals, standard operating procedures, and work instructions.
Lead, coach, and mentor a culture that embraces changes required to sustain product quality, reduce cost, and create competitive advantages.
Support company-wide medical device compliance with ISO 13485, ISO 14971, FDA, EU MDR, Health Canada, and other global regulations.

Requirements

Core quality management system skills include culture of inclusion, facilitation, root cause analysis, risk management, document development and management, data analytics and reporting, project management, training, and leading change.
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 and maintain compliance with best-in-class process discipline for Class 1/2 medical devices.
Experience in medical device manufacturing auditing, business integration, and Lean/Six Sigma.
Education, demonstrated skills, and experiences required to effectively lead teams in areas of responsibility.
Proven ability to manage high-performance teams in the execution of plans for on-time and within-budget goal achievement.
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.
Ability to coach, mentor, and train the organization in areas of responsibility.
Support internal and external audits and other ad hoc stakeholder needs.
Problem-solving skills, creativity, with a strong curiosity.
Understanding of Orthotics & Prosthetics (O&P) and/or healthcare business environment, the orthopedic industry, and the company’s markets is preferred.
Minimum 3 years medical device experience or healthcare quality assurance.
Advanced experience with medical device regulations and standards.

Skills

Lean & Six Sigma
ISO 13485:2016 auditing
Communications
Change leadership
Process deployment
Supplier audit support
Contract monitoring
Electronic system validation and monitoring
Process waste and defect reduction
Value stream capability & capacity analysis
Document management
Business integration
Root cause analysis
Corrective and preventative action
Risk management
Data analytics and reporting
Project management
Training
Lean/Six Sigma Green Belt (preferred)
ISO 13485:2016 Auditor Certified (preferred)

Location

Chesterfield
Kingston Upon Thames

Work Type

Office
Manufacturing
Onsite

Experience Level

Minimum 3 years medical device experience or healthcare quality assurance

Education Level

4-year degree in Engineering, Business, Healthcare, or equivalent background and experience

Benefits

Medical Insurance
Dental Insurance
Vision Insurance
Long & Short-Term Disability
Life Insurance and AD&D
Retirement Savings Plan
Paid Time Off (PTO) & Holidays

About the Company

OP Specialty Bracing is growing, and we believe our team is the key to our success.
We are a high performing global leader in our niche of pediatric medical device bracing.

Equal Opportunity

OPSB 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.