Design Quality Engineer
Exactech
QA Validation Engineer
Exactech
full-time
Posted on:
Origin: • 🇺🇸 United States • Florida
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Provides verification and validation expertise through IQ, OQ, and PQ protocol development and execution utilizing approved product and process validation SOP.
- Develop validation and verification plans and protocols for new product manufacturing (internally and externally) and related inspections.
- Participate in the validation of corporate software packages ensuring adherence to industry requirements.
- Execute activities related to the compliance of the sterility assurance program (e.g. Biocompatibility/Endotoxin testing, environmental monitoring, and quarterly dose audits).
- Execute activities related to the Exactech Analytical Laboratory (Analytical testing and reporting, equipment qualification, equipment preventive maintenance and equipment calibration).
- Prepare documentation and execute V&V activities utilizing a risk-based approach (pFMEA, FMEA, etc.) and Good Engineering Practices (GEPs) ensuring compliance to medical device industry regulations.
- Coordinate personnel training, protocol and process documentation/record retrieval supporting timely execution and closure of corporate V&V activities.
- Maintain corporate validation process auditing program ensuring timely completion of auditing activities.
- Work closely with QA management to maintain V&V planning (Validation Project Dashboard) documenting progress towards completion of corporate V&V initiatives.
- Participate in identification, maintenance, development and enhancement of corporate systems, processes and standards.
- Assist in identifying, analyzing and correcting internal and external manufacturing deviations, QE MRB related issues and anomalies related to V&V activities.
- Contribute to cross-functional project teams in device cleanliness and manufacturing V&V work such as material testing, specification development, process capability studies, research, investigation and process/test documentation.
- Participate in company-wide QE and validation related Corrective and Preventive Actions resulting from internal/external non-conformances, recalls and/or field actions.
- Participate in third party, customer and regulatory audits as required.
- Participate in E&D design control processes related to design inputs and define product/process inspection requirements for all current and new products.
- Analyze, justify, and recommend purchase of in house or vendor supplied inspection equipment.
- Responsible for QE related DCR product and process change review and approval.
- Know and apply the Quality System and appropriate Federal and International standards.
- Assist and support other employees, teams, and sales personnel and performs other tasks as necessary.
Requirements
- Bachelor’s Degree from an accredited institution required.
- Minimum 3 years experience in the medical device industry.
- Advanced level of technical software proficiency.
- Excellent Quality System knowledge required.
- Strong time management and project management skills.
- Experience writing IQ/OQ/PQ V&V protocols.
- Working knowledge of principles, concepts and practices of process V&V activities, Risk Management, FDA and ISO Regulations.
- General understanding of sterilization and related analytical testing is a plus.
- Must be able to work independently and in a team environment.
- Statistical expertise in areas such as process capability, process assurance and sampling.
- Understanding of US and International Medical Device Regulations and Standards.
- Familiarity with ISO 13485 and ISO 14971.
- Expertise in Microsoft Office products.
- ASQ Certifications preferred.
- Working knowledge of statistical analysis and sampling plans.
- Excellent communication (written and verbal) skills.
- Excellent organization skills.
