Rapidly growing Medical Device manufacturing company located in the Columbia, SC area is currently looking to hire a well versed Quality Assurance Engineer / QE / Quality Engineer to join their new manufacturing location. The idea candidate will have deep knowledge of FDA's 21 CR 820, ISO 13485, and EU MDD, knowledge in Class II medical devices (quality systems as well as processes) from development to product introduction and device maintenance. Experience with electromechanical systems a plus. The Quality Engineer should also have experience conducting audits and managing external audits conducted by regulatory agencies.
location: West Columbia, South Carolina
job type: Permanent
salary: $95,000 - 115,000 per year
work hours: 8am to 4pm
- Support development and manufacturing in the realization of the Company's Simplicity and future medical devices.
- Define quality plans and lead the effort for risk management and assessment, failure modes and effects analysis, and other quality specific deliverables.
- Leads quality oversight of all phases of the validation lifecycle. Influences the development and implements improvements to validation programs in partnership with impacted departments to ensure the program maintains compliance with current regulatory and industry expectations.
- Performs Quality Assurance review and approval for validation documentation, such as user requirement specification, IOPQ protocols & reports and product/validation impact assessments relating to material, equipment, cleaning, computer or process changes.
- Champion the companies change control system. Review/approve change controls.
- Review and audit the development team, including the project plan, specifications, protocols, and the design history file.
- Oversee documentation control and interface with external quality consultants.
- Support manufacturing engineering in qualifying critical suppliers.
- Identify and help establish systems for the creation of a controlled manufacturing facility.
- Manage the Company's Quality Management System.
- Manage the auditing efforts, both internal and external, consistent with ISO 13485 and EU MDD.
- Oversee the Document Control functions, including administration of the electronic Document Management System and the Engineering Change Control process.
- Manage Corrective Action and Preventive Action activities.
- BS in Engineering; Master's in Engineering preferred.
- 5 plus years in a Quality Engineering department for the development manufacture of medical devices.
- Basic knowledge and proficiency in the application and principles of Quality Engineering and Validation.
- Knowledge of change controls in a regulated industry.
- Deep knowledge of FDA's 21 CR 820, ISO 13485, and EU MDD.
- Solid understanding of Quality Management Systems, implementation approaches, and maintenance.
- Experience conducting audits and managing external audits conducted by regulatory agencies.
- Knowledge in Class II medical devices (quality systems as well as processes) from development to product introduction and device maintenance. Experience with electromechanical systems a plus.
- strong statistical foundation necessary to help define verification plans and document verification results.
- strong verbal and written communication skills.
- Six Sigma Green Belt or Black Belt Certification desirable.
- Self-motivated, team-oriented individual who collaborates and communicates effectively with local and international team members in a cross-functional, multi-cultural, interdisciplinary environment.
- Comfortable working in an extremely dynamic and fast paced environment, and able to meet aggressive a realistic development milestones.
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
- Six Sigma
- Quality Engineer
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.