Job: QA/RA Director

Title QA/RA Director
Number of Positions 1
Location Cleveland, OH
Overview

Who we are:

R&Q Solutions focuses on providing support to medical device companies in the Western Pennsylvania and Eastern Ohio Regions, as well as their suppliers. The company provides on-site, concise, and complete service from an idea’s conception to fulfillment of vision. R&Q Solutions provides support ranging from individual projects to complete client team augmentation (i.e., R&Q Solutions serves as the Regulatory and Quality Department for the client organization). R&Q Solutions’ services include, but are not limited to, training and/or service in the following areas: Regulatory leadership, planning and submissions; Quality Assurance Leadership Activities; Quality System Development and Enhancement; Design Assurance Engineering Activities and Documentation; Safety and Risk Management Activities and Documentation for new products and field issues/recalls; Auditing to ISO 13485:2003 and QSR; Clinical Trial Strategy Development and Management; and Venture Capitalist Due Diligence.

Benefits: Competitive salary,Medical, Dental, Vision, Employer match 401(k), Short and Long Term Disability, Group Life and AD&D Insurance, Paid Time Off, Paid Holidays, Bonus Compensation Programs, and Training

The Role of the QA/RA Director is to provide regulatory and quality related guidance and support to R&Q Solutions’ clients. The position is open to full time candidates as well as part time candidates willing to work a minimum of 24 hours a week.

Responsibilities

Regulatory:

  • Lead regulatory and quality activities on new product development teams
  • Prepare and Submits Design Dossiers and Tech Files for EU
  • Lead writing/reviewing product labeling
  • Review and approve marketing literature
  • Lead and develop complex world-wide regulatory strategies
  • Lead and develop regulatory assessments and strategies in support of new product initiatives and product line extensions
  • Ensure compliance with all applicable regulations and standards
  • Monitor the regulatory competitor landscape and keep the organization abreast of potential threats and opportunities
  • Monitor changes to domestic and international regulations and standards & assess impact on company / clients
  • Lead regulatory submissions for other key areas of the world (Asia/Pacific, the Americas)
  • Provide regulatory intelligence information to the organization
  • Provide Daily Support to Product Regulatory Teams
  • Provide an independent review of deliverables assigned to other RQS staff to ensure high technical quality that will meet customer and regulator expectations

Quality Compliance:

  • Conduct client internal and external audits to QSR/ISO13485/MDD requirements
  • Assist with product recalls
  • Lead the development of corporate policies and procedures
  • Develop training presentations
  • Lead/Assist in government agency audits and respond to audit findings
  • Support QSR/ISO training
  • Lead customers with regard to compliance to ISO13485:2003 with a Business Balanced Approach
  • Lead and complete supplier audits to ISO 13485-2003
  • Lead and complete RQS Internal Company Quality Audits
  • Lead and conduct Quality & Regulatory Training for Clients
  • Lead and develop Quality Systems per ISO13485:2003 for Clients
  • Lead and develop Quality System Plans
  • Oversee and Close Quality Audit Findings
  • Lead Acquisition Integration activities for Clients
  • Assist with completion of Due Diligence for Venture Capital
  • Plan Quality Systems implementation & ensures all recommendations to clients are approved by RQS Management as per company policy
  • Ensure all recommendations and deliverables are approved by the client as per company policy
  • Monitor the competitive landscape and advice organization on actions to be taken with regard to opportunities or threats
Qualifications

Education/ Training Requirements:

  • Bachelor level degree in engineering or a technical field – required
  • Advanced degree – preferred
  • Working knowledge of FDA Quality System Regulations, EU Medical Devices Directive and International Electric Safety Standards – required
  • CQA/CQE/Certified Lead Auditor Training – preferred
  • Advanced computer skills including business applications, statistical data analysis and report writing – required
  • Regulatory Affairs Certification (RAC) – highly preferred

Experience Requirements:

  • 15-20 years work experience – required
  • 10-15 years of experience in the medical device industry –  required
  • 7 -10 years experience in preparing 510(k)/PMA, design dossiers and technical files submissions for disposables, software, and electromechanical devices – highly preferred
  • Previous quality engineering experience and demonstrated use of quality tools and methodologies – preferred
  • Experience with worldwide regulatory registrations – preferred
  • Knowledge of safety and risk management per ISO 14971 – desired
  • Development and creation of entire ISO 13485 compliant quality systems – preferred
  • Experience with test method development and qualification – preferred
  • Track record of successful new business development – preferred
  • Demonstrated persuasion and consensus building skills – preferred

Behavioral Requirements:

  • Project management and creative leadership skills including the demonstrated ability to lead multiple, simultaneous projects to resolve issues and achieve results in a timely and effective manner
  • Demonstrated high performance orientation, detail orientation, and strong organization skills
  • Excellent interpersonal communication and influencing skills as well as experience working collaboratively with clients, employees, and outsiders
  • Ability to communicate both orally and in writing with customers at all levels and articulate customer needs accurately
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