Job Description
About us Founded with a vision to make a tangible difference in the world, Trulife has grown into a trusted name in the medical device industry and beyond with a reputation for safe, simple, and reliable devices. Over the years, we have evolved, but our core values of customers, people, quality, and integrity have remained steadfast. We are seeking a detail-oriented and experienced Quality Systems Coordinator to join our team. You will be responsible for sustaining and improving the Quality Management System (ISO13485) to ensure that our products meet the highest quality standards and comply with all relevant regulations as well as create, implement, and maintain work instructions based on process flows. This role requires excellent interpersonal and communications skills, knowledge of quality and safety regulations, and the ability to develop and deliver quality and safety training programs.
Responsibilities:
Oversee and maintain our Quality Management System, ensuring full compliance with ISO standards (ISO 13485) Manage FDA and EU MDR regulatory compliance. Develop and maintain quality documentation, including standard operating procedures (SOPs) and work instructions in accordance with the standard. Manage the Corrective/Preventive Actions process, driving solutions to closure and addressing audit findings and customer issues. Schedule, coordinate, and conduct both internal and external audits. Maintain Supplier and Customer monthly Scorecards, sending out monthly reports to suppliers shown on the Preferred Supplier list. Collaborate with cross-functional teams to maintain, enhance, and implement quality systems and processes. Engage with customers and customer service to resolve quality issues, including site visits and communication as required. Manage customer returns; lead investigations into non-conformances and customer complaints, identifying root causes and implementing corrective actions. Provide training to employees on quality systems, procedures, and best practices. Stay up to date with changes to the ISO13485
standard as well as industry's best practices. Support the development and implementation of continuous improvement initiatives. Perform other duties as assigned. Education/experience:
A bachelor's degree in engineering, or other relevant scientific discipline, and at least one year experience in regulatory affairs or quality management system relating to medical devices - OR - four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. Previous ISO 13485
experience, FDA and EU MDR experience, highly preferred. Previous ISO 9001 and AS 9100 experience a plus. Experience in conducting ISO or regulatory audits; certified auditor a plus. Proficient in technical and report writing, strong verbal and presentation skills, able to effectively liaise with all levels of facility personnel, customers, and suppliers. Strong knowledge of quality management principles, practices, and methodologies. Experience with an ERP system (SAP) a plus. Ability to conduct root cause analysis, analyze data, identify trends, and make data-driven decisions. Initiative, independence, and the ability to work effectively with minimal supervision. Proficient in project management techniques, including planning, organizing, and monitoring project progress. This position offers the opportunity to work in a dynamic environment where your attention to detail and commitment to quality will make a significant impact. Join us in ensuring our products meet the highest standards of excellence. Must be a U.S. citizen or national, U.S. permanent resident (current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum. Trulife is proud to be an Equal Opportunity Employer and is committed to attracting, retaining, and developing a highly qualified, diverse, and dedicated work force. Trulife hires and promotes people on the basis of their qualifications, performance, and abilities. We support the establishment and maintenance of a workplace that fosters trust, equality, and teamwork, in which all employees recognize and appreciate the diversity of individual team members. We provide all qualified applicants for employment and employees with equal opportunities for hire, promotion, and other terms and conditions of employment, regardless of their race, color, religion, gender, sexual orientation, gender identity, national origin/ethnicity, age, physical or mental disability, genetic factors, military/veteran status, or any other status or characteristic protected by federal, state, and/or local law. Applicants requiring reasonable accommodation in order to participate in the application and/or interview process, please contact us at 360-598-8977. Job Type:
Full-time Pay:
$28.00 - $34.00 per hour Benefits:
401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Life insurance Paid time off Retirement plan Tuition reimbursement Vision insurance Application Question(s): What experience do you have with FDA? Have you conducted an ISO13485
audit? Have you worked with a Quality Management System? Education:
Bachelor's (Preferred) Experience:
Quality Management regulatory: 4 years (Required) Work Location:
In person
