Quality Management Systems Specialist II - Express Employment : Job Details

Top Job Located in Newberg, OR Salary: $62,000 - $93,000Quality Management Systems Specialist II$62,000 - $93,000The Quality Management System (QMS) Specialist is responsible for developing, implementing, maintaining, and continuously improving the organization's Quality Management System specifically tailored to the medical device industry. This role ensures compliance with applicable industry standards, regulatory requirements (such as FDA regulations), and best practices. The QMS Specialist collaborates with cross-functional teams to enhance quality processes, facilitate audits and drive quality initiatives that support the company's strategic objectives, ensure patient safety, and enhance customer satisfaction.Primary Duties and Responsibilities:? Assist in reviewing and updating processes to comply with the current regulatory requirements.? Analyze the issues related to the application and implementation of policies, procedures, and practices.? Coordinate and conduct internal quality audits and support external audits by regulatory bodies and notified bodies.? Identify non-conformities, analyze root causes, and implement corrective and preventive actions (CAPA) in accordance with medical device regulations.? Prepare comprehensive audit reports and track the implementation of audit findings to ensure timely resolution.? Assist the Regulatory Affairs Management in establishing and reporting quality metrics.? Develop and deliver training programs related to the QMS and regulatory requirements for employees across the organization, focusing on medical device-specific topics.? Provide guidance and support to departments on quality-related matters, ensuring adherence to QMS procedures and regulatory requirements.? Work closely with all involved departments to bring labeling processes to MDR compliance.? Work closely with continues improvement manager on bringing CAPA projects to resolution.? Perform other tasks and projects as needed and assigned by managerEducational and Skill Requirements:? Practical knowledge of compliance and regulatory requirements.? Experience in process design and implementation and change management.? Work independently with general supervision.? Strong communication skills, both written and verbal; good intrapersonal skills and the ability to work with cross functional stakeholders and work in a fast-paced environmentprone to change. Strong attention to detail and ability to support multiple projects and meet deadlines.? Proficiency with Microsoft Office suite? Bachelor's Degree in related field from an accredited college or university, and at least three (3) years of experience in regulatory environments; or an equivalent combinationof education and/or experience.Experience Desired:? Demonstrated experience with direct support of multiple projects? Demonstrated experience participating on cross functional teams? Demonstrated knowledge of regulated industry. Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements? FDA regulated environment experience is strongly recommended? Experience with and knowledge of domestic and international quality? Personal computer hardware and software applications such as databases, spreadsheets, project management software, word processing and presentation software? Other qualifications include attention to detail, organizational skills, precise written and verbal communication, and the ability to work in a team setting. Ability to identifyproblems and quickly escalate for resolution#MacAdminExpress Office: McMinnville 733 Northeast Baker StreetMcMinnville, OR 97128