Job Description

Job DescriptionJob Description

Duties and responsibilities:

• Actively work with engineers with equipment assembly and execution of installation and operational qualifications
• Develop, implement, and maintain the company’s Quality Management System (QMS) in accordance with ISO 13485 to meet other relevant standards (MDR and FDA).
• Work closely with product development and manufacturing teams to ensure adherence to quality assurance procedures and requirements and ensure that products meet reliability and quality expectations.
• Hands-on responsibility for quality management system and regulatory compliance, including, but not limited to: document control, design control, risk management, process validation, manufacturing controls, personnel training, quality audits, supplier evaluation, product inspection/testing, nonconforming product control, corrective/preventive actions, product sterilization.
• Manage internal quality audits and external regulatory inspections.
• Analyze product complaints and post market surveillance data and prepare summary reports.
• Work with cross-functional team to streamline design documentation for regulatory submissions.
• Quality and Regulatory documentation consists of design specifications, manufacturing procedures, test methods, specification, and manufacturing drawings and other per quality and regulatory requirements.
• Monitor and interpret regulatory developments and communicate implications to the executive team.
• Lead and mentor the Quality and Regulatory Affairs team, fostering a culture of quality and compliance throughout the organization.
• Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure quality and regulatory considerations are integrated into all phases of product development and commercialization.
• Ensue QMS system meets FDA and MDR requirements, work with team members to improve quality and characterization test reports.
• Communicating test results concisely and in a timely manner
• Perform other project tasks as assigned.

Qualifications:

• Excellent written and verbal communication skills
• Strong teamwork and organizational skills
• Ability to work cross-functionally with Electrical, Mechanical, Software, and Quality teams.
• A self-starter, ability to complete assignments in a timely manner.
• Ability to work independently with minimal daily oversight.
• Knowledge of statistics and statistical tools is .

Other:

• Prior medical device industry 3 to 5 years’ experience is but not required.
• Individuals must have strong organizational skills and is willing to learn and develop.
• An engineering degree is or progressing towards completing education.

Company DescriptionWe are a Michigan based start-up implantable medical device company. Our mission is to design, develop, manufacture, and integrate MEMS (micro electromechanical sensors) technology to help manage patients with congestive heart failure.Company DescriptionWe are a Michigan based start-up implantable medical device company. Our mission is to design, develop, manufacture, and integrate MEMS (micro electromechanical sensors) technology to help manage patients with congestive heart failure.

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