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Remote

Key Responsibilities:

We are seeking an experienced and detail-oriented Principal Quality Engineer to join our dynamic team. This role will focus on the remediation of Design History Files (DHF) to ensure compliance with regulatory standards and enhance the overall quality and safety of our medical devices. The ideal candidate will possess in-depth knowledge of medical device regulations, quality management systems, and a strong background in design controls.

Key Responsibilities:

1. DHF Remediation:
   • Lead the remediation of Design History Files (DHF) to ensure compliance with FDA, ISO 13485, and other applicable regulatory requirements.
   • Review and update DHF documentation, including design plans, design inputs, design outputs, design verification and validation, risk management, and design reviews.
   • Ensure all DHF documentation accurately reflects the design and development process and meets regulatory standards.

2. Quality Assurance:

1. • Develop and implement quality assurance processes and procedures to support DHF remediation activities.
   • Collaborate with cross-functional teams, including R&D, Regulatory Affairs, and Manufacturing, to ensure comprehensive and compliant DHF documentation.
   • Conduct internal audits and participate in external audits to ensure DHF compliance and readiness.

3. Regulatory Compliance:

1. • Stay current with global regulatory requirements and standards related to medical device design and quality management systems.
   • Provide guidance and training to team members on regulatory requirements and best practices for DHF documentation.
   • Ensure the company's quality system is compliant with all relevant regulations and standards.

4. Risk Management:

1. • Conduct risk assessments and manage risk management activities related to design controls and DHF remediation.
   • Implement corrective and preventive actions (CAPA) to address identified risks and non-conformances.

5. Continuous Improvement:

1. • Identify opportunities for process improvements and efficiencies within the quality management system and DHF documentation process.
   • Lead continuous improvement initiatives to enhance product quality, safety, and compliance.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 8-10 years of experience in quality engineering within the medical device industry.
• Extensive experience with design controls and DHF remediation.
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.
• Proven ability to manage and lead cross-functional teams.
• Excellent analytical, problem-solving, and organizational skills.
• Strong written and verbal communication skills.
• Certification in quality engineering (CQE) or related certification is a plus.

Skills and Competencies:

• Attention to Detail: Meticulously review and update documentation to ensure accuracy and compliance.
• Regulatory Knowledge: Stay updated on regulatory changes and ensure company compliance.
• Project Management: Manage multiple projects and priorities effectively.
• Team Collaboration: Work collaboratively with cross-functional teams to achieve common goals.
• Problem Solving: Identify issues and develop effective solutions to improve quality and compliance.

Requirements

• Ability to present all information (regulatory and scientific) effectively, both orally and in writing, in a concise, logical, and persuasive manner with excellent written and interpersonal communication skills.
• Provides guidance on drug regulations, regulatory strategy, and pharmaceutical and design controls/design history file deliverables to other combination product regulatory professionals.
• Set and communicate timelines for the regulatory submissions and for the delivery of supporting documentation. Ability to work with all functional areas to obtain needed information on time.
• Anticipates the impact of potential team decisions on the regulatory strategy, timelines, project goals, and other programs and influence the team as needed.
• Reviews scientific information to ensure the data is complete, sound, logical, and supports the program goals.
• Partners with authors to ensure supporting information is clearly and logically written, in order to ensure it is submission ready.
• Interact and effectively negotiate with regulatory authorities
• Maintains awareness of applicable regulations and guidances and informs project teams of new information, along with its possible impact to the project, as appropriate.

Qualifications

• 10-15 years of experience in regulatory affairs, research, development or related area with experience working with RA.
• Significant experience in both pharmaceutical and medical device regulatory affairs required.
• Previous experience with combination product regulatory strategy and/or execution is strongly preferred