Dynatronics seeks a qualified Quality Engineer I to support maintainingprocess and drive improvements to the quality system while providing quality assurance support to operations for product development, design, and changes, ensuring quality activities are conducted in compliance with Standard Operating Procedures (SOP) and in accordance with the Quality Manual and applicable regulatory requirements.The Quality Engineer I is also instrumental in managing document control for the quality system by developing, administering, maintaining, and monitoring Dynatronics’ document control activities in accordance with FDA/QSR, ISO 13485 requirements and other international regulations.
Responsibilities:
- Support the development and implementation of standards and methods for inspection, testing, and evaluation; performing product, process, and work procedure audits to ensure understanding and compliance; and closely monitor results to assure quality of product and alignment with customer needs and company objectives
- Support the review and approval of documentation supporting design, qualification, and changes; responsible for compliance with 21CFR Part 803 (Medical Device Reporting), and 21CFR Part 806 (Medical Devices, Reports of Corrections and Removals) under the FDA
- Partner with cross-functional teams from all departments of the organization (e.g., IT, R&D, Clinical, Marketing, Sales, Manufacturing, Supply Chain) to drive product quality and production process controls and improvements
- Support the design and implementation of quality training programs, coaching, and support to ensure understanding of quality philosophy by all employees, and effective qualification and change processes are known and maintained
- Assist with duties in Quality Assurance including NCMR, CAPA, Complaints, Audits, Labeling, Inspections, etc., as applicable and needed
- Maintain equipment calibration and preventive maintenance schedule
- Responsible for implementation and management of the Document Control System, establishing and maintaining procedures for inspection readiness, good documentation practices, and change control
- Determine document management policies to facilitate efficient, legal, and secure access to electronic content
- Evaluate and develop improved techniques and use of tools for the control of documents and quality records, including, but not limited to, the assessment, acquisition, or deployment of new electronic document management systems; develop or configure document management system features, such as user interfaces, access profiles, and document workflow procedures; maintain onsite and offsite documentation storage as applicable
- “Proof” review during document initiation or changes to ensure basic requirements are met for specifically required elements (i.e., header, footer, style, formatting, required approvals) and ensure the organization’s needs for documentation infrastructure are met, with compliance to all applicable statutory and regulatory requirements
- Keep abreast of developments in quality engineer technologies and techniques by reviewing current literature, talking with colleagues, participating in educational programs, attending meetings or workshops, or participating in professional organizations and conferences
- Participate in on-site inspections and audits by internal personnel or external agencies
- Perform additional, related duties as needed
Qualifications:
- Knowledge of regulatory requirements for medical devices in global markets, including US, EU and Canada; FDA Quality System Regulation, ISO 13485, and Current Good Manufacturing Principles (cGMP)
- Strong understanding of continuous improvement and other lean manufacturing techniques, including, but not limited to, applying statistical process control (SPC), modern quality tools such as Design of Experiments (DOE) and Failure Mode Effects Analysis (FMEA), Kaizen, “5 S,” and Six Sigma methods for analyzing data to evaluate current process and process changes
- Strong understanding of engineering specifications and mechanical assembly drawings
- Strong problem-solving, strategic-thinking, and critical-analysis ability; ableto make effective decisions and execute an appropriate course of action that complies with quality and regulatory requirements while supporting business objectives
- Ability to skillfully gather, review, summarize, interpret, and analyze data; able to conduct root-cause investigations, and prepare reports on findings in a resourceful manner
- Strong attention to detail; strong time management, project management, and organizational skills; able to perform a wide variety of tasks and multi-task efficiently
- Influential, high level of verbal and written (including technical writing) communicationskills; must speak, read, and write English fluently
- Ability to work independently, with minimal supervision, and also work on a team
- Exceptional customer service and interpersonal skills, able to maintain rapport and work effectively cross-functionally and with external customers (e.g., clients/customers, dealers, vendors, contractors)
- Proficient in Microsoft Office application (Outlook, Word, Excel, PowerPoint); proficient with business management (enterprise resources planning; ERP) and quality and regulatory software
- High level of integrity and ethics, able to handle sensitive and proprietary information with discretion and confidentiality
- Ability to remain calm under pressure and work to deadlines in a fast-paced manufacturing environment
- Quality #1 commitment; continuous-improvement, entrepreneurial, and proactive mindset
Benefits
Dynatronics offers competitive wages and benefits, including medical, dental, vision, disability, life insurances; paid time off (PTO); a 401(k) retirement plan; and a great company culture and work environment.
Schedule: Monday through Friday from 8:30 a.m. to 5:00 p.m. with 30 minutes for lunch
To Apply:
To be considered for this position, submit your cover letter and resume to
careers@dynatronics.com.
