Aug 16, 2021

Regulatory & Quality Engineer

  • Bone Foam Inc.
  • Corcoran, MN, USA
Full time Engineering Product Development Quality Regulatory R&D

Job Description

Job purpose 

The purpose of the Quality Engineer, Regulatory Compliance position is to represent Bone Foam’s commitment to “innovating the highest quality solutions that optimize safety, efficiency, cost and clinical experience” by leading the implementation and ongoing efficacy of Bone Foam’s quality management system. Bone Foam is a design specification owner and complaint file establishment that works with contract manufacturers to bring patient positioning devices to market. This position is responsible for leading both up and down the chain of command to exercise discretion over company’s quality needs, global regulatory strategy, and lead strategic development and implementation of solutions by collaboratively educating departments where relevant. It is expected that this position will own responsibility for Bone Foam’s quality and regulatory compliance and represent and advance its mission and core values. It is imperative that the quality & regulatory compliance supervisor implements and maintains a quality management system that is simple, agile and maintains efficacy in conformance to ISO 13485.  

Duties and responsibilities 

  • Provide operational leadership in planning, implementation, and management of quality system activities, including but not limited to: 
    • Identify conformance and compliance gaps, particularly with ISO13485:2016 and 21 CFR 820, against Bone Foam’s existing policies and procedures and formulate objectives and priorities and implement plans consistent with long-term interests of the organization in a global environment. Capitalize on opportunities and manage risks, collaborating with other departments to share best practices and align where appropriate 
    • Measurement, analysis, and improvement programs, including quality trending, ensuring costs associated with poor quality are captured  
    • Quality training programs 
    • Partner with suppliers to carry out failure analysis and ensure supplier corrected the issues and prevent re-occurrence  
    • Lead, conduct and participate in quality audits (internal & external) 
    • Identify technology and tools to improve efficacy of quality processes and procedures  
    • Product labeling, including unique device identifiers and UDI databases (GS1, GUDID, EUDAMED, etc.) 
    • Quality engineering (including testing, validations, verifications, investigations) 
    • Document control & Change management with a focus on standards and compliance excellence, maintaining personal and department effectiveness during major policy, organizational, department or team changes 
    • Continued development and use of the electronic document and record control system (Greenlight Guru) 
    • Product assembly and production processing in times of need 
    • Prepare and ship product samples to customers as requested by sales 
    • Lead Material Review Board and disposition of Non-Conforming Materials. 
  • Develop and implement global regulatory and compliance strategies with external support from consultants to: 
    • Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy; 
    • Distribution management support with respect to country licensure/registration  
    • Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirements 
    • Ensure all advertising and promotion materials conform to applicable FDA, FTC and, where applicable, other country regulations. 
    • Ensure post-market surveillance obligation in accordance with Article 10(10) 
    • Ensure technical documentation and EU declaration of conformity are maintained and updated 
    • Comply with Vigilance Reporting obligations outlined in Articles 87 to 91 
  • Serve as the expert on the overall structure, contents, and interpretation of the various regulatory requirements Bone Foam is subject to. Collaborate with departmental management and system owners to determine applicability and any actions needed. 
  • Overseeing on the filing of necessary applications, leading and positively impacting government interactions pertaining to the regulation process for products requiring governmental approval in the US and other international markets Bone Foam wishes to enter 
    • Manage the internal or external staff associated with these activities. Preparation of future 510k application if necessary and authoring relevant sections and narrative to support filings. 
  • Make formal presentations to executive management, auditors, regulators, customers and/or staff on quality-related activities 
  • Take action or generate alternative solutions to resolve complex quality or product problems 
  • Foster the development of a common vision and fully participate in creating a unified leadership team that gets results 
  • Build effective working relationships with other departments to ensure timely completion of objectives and milestones, and to manage project- and team-related challenges 
  • Develop action plans with staff to ensure the continued success of the organization, ensure team’s work is done effectively, accurately and on time 
  • Participate in continuing education programs (self-study, seminars, etc.) to maintain currency of knowledge and apply new learning to the job 
  • Willingness to wear multiple hats and contribute in variety of different business functions outside of quality  

 Qualifications  

  • Qualifications for the Person Responsible for Regulatory Compliance are stated in Article 15 of the EU MDR 2017/745 / IVDR 2018/746. 
  • Bachelor’s or Master’s degree in a biological science, Engineering, or Health Sciences preferred  
  • Demonstrated ability to build commitment across a range of teams and at all levels of the organization, tactfully overcoming resistance; prepares and supports those affected by change  
  • Positive attitude, inspires others toward continuous quality improvement  
  • Direct experience with US Class I and Class II devices. EU medical device (Class I, Class Im, Class lla or higher) CE- marking preferred. 
  • Prior experience in worldwide post market surveillance reporting preferred. 
  • Must have experience with applying ISO 14971 principles to medical devices throughout all stages of the product’s lifecycle. 
  • Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner. 
  • Professional certification (RAC/ASQ/CQE) preferred. 
  • Working knowledge of cGMP/QSRs, FDA device regulations, ISO 13485 
  • Understands and can apply regulations and standards to new situations 
  • Ability to build, identify and/or utilize efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metrics 
    • Experience with eQMS software Greenlight Guru preferred 
  • Ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, trend reports 
  • Ability to communicate effectively both orally and in writing 
  • Previous experience with statistical charting 
  • Previous experience with Quickbooks Enterprise, preferred 
  • Previous experience with electro-mechanical device development and software device design for future product developments desirable. 
  • Readily adapts to changing priorities, and effectively manages own time to ensure tasks, projects are completed on time to meet growth objectives 
  • Ability to take responsibility for quality of all products including assembly, testing and yields. Understanding and familiarity with design control processes including design history files, device master records, device history records, manufacturing process/assembly instructions, MRB, failure analysis and corrective/preventive actions and verification testing; 
  • Knowledge and experience with continuous improvement techniques such as Lean Enterprise, Six Sigma, Kaizen, etc. is desirable; 
  • Strong research, analytical, and problem-solving skills. 
  • Working knowledge of technical standards, including IEC 60601, IEC 61010, IEC 62366 for establishing the safety and effectiveness of medical electrical equipment desirable for future product developments. 
    • Premarket Experience: Experience supporting medical device regulatory submissions (e.g., 510(k)s and/or PMAs) preferred; proven experience with application of quality and regulatory requirements in the design and development of medical devices. 
    • Postmarket Experience: Proven experience with recalls, corrections, removals, and MDRs preferred. 

Working conditions 

  • Ability to work long work weeks when necessary and travel up to 20% 

Physical requirements 

  • Ability to perform necessary travel obligations as well as functions within the operating room environment when necessary for product testing or validation 

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