MiRus is a privately held medical device company focusing on the design and manufacturing of cardiovascular, orthopedic, and spinal systems based on innovative designs making use of proprietary technologies. The company is experiencing rapid growth in the orthopedic and spinal areas while bringing new technologies to the cardiovascular space. The company provides opportunity for advancement and professional growth, as there is a high level of visibility to all roles within the organization with a high level of recognition for your contributions.
The Quality Engineer position uses Quality Engineering and Quality Assurance techniques to provide functional support for new product development and product line support. This position also ensures that the company complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products..
- Directly support CAPA, training, audit preparedness, and quality system efficiencies in a medical device environment.
- Support compliance in all phases of design and development, manufacture, and product release.
- Author, review and approve SOPs, protocols, test reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and internal procedures.
- Maintain Quality Activities-deviations, non-conformances, CAPAs, customer complaints, process change controls, etc.
- Creates and/or refines test strategies, plans, and metrics with guidance.
- Perform Internal or Supplier Quality System Audits, as assigned.
- Bachelor’s Degree in engineering, science, or technical field with 2+ years of experience in quality, engineering, operations and/or program management in a medical industry.
- Working knowledge of 21 CFR Part 820 (Quality System Regulation), ISO 13485, EU Medical Device Directive, and relevant international standards
- Knowledge of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, DFMEA)
- Knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
- Assertive, take-charge, results orientated, positive “can do” attitude and a sense of urgency to get things done.
- Highly detailed orientated with a critical degree of accuracy regarding data entry and analysis.
- Ability to collect and analyze information, problem-solve, and make decisions.
- Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
- Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others’ needs, negotiate for win-win, own the whole)
- ASQ, CQE, CQA Certification preferred, but not required.
- Must be legally authorized to work in the United States
- Must be willing to submit to a pre-employment background check and drug screen
Location: Marietta, Georgia
Employee Type: Full-time