Quality Assurance Engineer

OP Specialty Bracing is growing, and we believe our team is the key to our success. We are hiring a Quality Assurance Engineer to join our team. If you are a motivated, caring individual who wants to make a difference in the lives of children, we encourage you to apply today!

GENERAL SUMMARY: The Quality Assurance Engineer will support the OP Specialty Bracing (OPSB) international multisite integrated quality management system. The ideal candidate will be an entrepreneur with proven experience in international regulatory and medical device quality system compliance, product realization processes, Lean & Six Sigma, ISO 13485:2016 auditing, strong skills in communications, and change leadership through process deployment.

This is a key role in supporting the goals of business optimization and sustainment for a high performing global leader in our niche of pediatric medical device bracing. This position will support the team in providing quality system support through business integration with two newly acquired medical device manufacturing sites in the United Kingdom, with site presence required in both locations throughout the duration of acquisition integration plan activities. The continued focus for this position will support the team in providing quality system leadership through contract manufacturing/ 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, and corrective and preventative action.

PERFORMANCE RESPONSIBILITIES:

Quality Management System:

• Responsible for supporting an ISO 13485:2016 compliant medical device manufacturer; medical bracing solutions.

• Lead Business Optimization & Sustainment Quality Pillar.

• Support implementation of business integration activities as assigned through acquisition integration plans.

• Conduct supplier, contract manufacturer, and distributor internal audits.

• Develop and execute validation plans (software and support with manufacturing facilities/ equipment)

• Summarize critical activities for quality management system integration, monitoring, and optimization.

• 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.
• Perform all other duties as assigned by manager.

Technical Communications:

• Support technical communication development and/ or revision including but not limited to; software, equipment, and facilities IQ/OQ/PQ-validation plans, value stream maps, audit assessments and reports, supplier/ distributor corrective action planning, system waste reduction planning.
• 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 create competitive advantages.

Compliance :

• Support company-wide medical device compliance with ISO 13485, ISO 14971, FDA, EU MDR, Health Canada, and rest of world.

QUALIFICATIONS:

• Core quality management system skills include 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.

• 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 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 defined above.

• Proven ability to manage high-performance teams in the execution of plans for on time and within budget goal achievement.

Other skills, Abilities, and Requirements:

• 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 with Lean/ Six Sigma Green Belt-preferred.

• Problem-solving skills, creativity, with a strong curiosity

• Provide site support for multiple international sites, travel is expected at routine intervals.

• Understanding of Orthotics & Prosthetics (O&P) and/ or healthcare business environment, the orthopedic industry, and the company’s markets is preferred Education and/or Experience.

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

• Minimum 3 years medical device experience or healthcare quality assurance.

• ISO 13485:2016 Auditor Certified-preferred.

• Advanced experience with medical device regulations and standards.

WORKING CONDITIONS:

• Office and manufacturing
• Regular Domestic & International Travel; multiple sites
• Site Travel (Acquisition Integration Support); Chesterfield and Kingston Upon Thames

PHYSICAL DEMANDS:

• Limited warehouse and manufacturing process activities

• Occasional light lifting to 25 pounds

*This job description is not intended to be and should not be construed as an all-inclusive list of all the responsibilities and working conditions of the position. While it is intended to accurately reflect the position of activities and requirements, management reserves the right to modify, add or remove duties and assign other duties as necessary

Benefits Offered for Eligible Employees:

• Medical Insurance

• Dental Insurance

• Vision Insurance

• Long & Short-Term Disability

• Life Insurance and AD&D

• Retirement Savings Plan

• Paid Time Off (PTO) & Holidays

Equal Opportunity Employer:

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.

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