October 21, 2019 Senior Quality Assurance Engineer
The Senior, Quality Assurance Engineer works under the instruction of the Head of Quality. This position helps to support the manufacturing of medical devices from a quality perspective.
Duties and responsibilities
- Develop Quality System Processes in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device regulations.
- Develop Quality Plans for implementation of new processes or improvements to existing processes
- Conduct internal quality audits to ensure compliance to Quality System and regulatory requirements.
- Facilitate receiving inspection and first article inspection activities. Help establish receiving inspection requirements for materials and any needed inspection/testing procedures.
- Facilitate calibration activities by monitoring calibration logs to ensure on-time calibration, working with inspectors, development of calibration requirements and test methods.
- Control of suppliers including supplier approval, supplier audits, supplier monitoring and supplier corrective action.
- Facilitate material review board meetings. Establish and maintain non-conforming material system.
- Daily line support activities in manufacturing.
- Support manufacturing in process validation activities.
- Establish and maintain corrective/preventive action system. Work with responsible engineering personnel to perform root cause analysis, develop and implement action plans, and follow-up on implementation and effectiveness of actions taken.
- Collection and trending of key quality indicators for management review.
- Support transfer of products from development to manufacturing.
- Perform other related functions as required by quality management.
- Bachelor’s degree in a technical field as Engineering or Biological Science and a minimum of eight-years experiences in the field of medical device manufacturing quality assurance, prior experience with medical electronics preferred;
- Ability to work with minimal direct leadership in a fast-paced environment;
- Ability to read and interpret engineering drawings, schematics and specifications;
- Self-motivated, detail oriented, and well-organized with good communication skills, both written and oral.
- Strong analytical problem-solving ability required;
- Proficient computer skills which include the use of Microsoft WORD, EXCEL, and POWERPOINT. Prior use of an electronic document control system, ERP system and FDA eMDR reporting.
- ASQ Certifications such as Manager of Quality/Organizational Excellence, Quality Engineer, Quality Auditor, Supplier Quality Professional, etc.
- Certified ISO 13458 / MDD lead auditor.
- A Senior, Quality Assurance Engineer usually works in an office environment which includes laboratory and manufacturing areas. Occasional domestic travel may be required.
- A Senior, Quality Assurance Engineer works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.
- Must be able to type using the keyboard of a computer.
- Must be able to talk, listen and speak clearly on the telephone.
- Must be able to lift and carry up to 50 lbs.
This job description defines the essential job duties of this position. The Company expects that employees hired for this position can perform the essential functions of this job without imposing risk of substantial harm to the health or safety of themselves or others. It may also include marginal functions, generally defined within Title I of the Americans with Disabilities Act (ADA) and the Occupational Safety and Health Administration (OSHA). In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.
This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this position. Additional functions and requirements may be assigned by supervisors as deemed appropriate. When duties and responsibilities change and develop, the Company will review this job description and make changes of business necessity. Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. An employee may resign at any time, with or without reason, and the Company may terminate employment at any time, with or without reason.
|Job Category||Quality Assurance|