Quality Assurance Engineer Job Duties:
· Implement sound and relevant quality engineering and compliance methods and principles to support development, qualification, and on-going manufacturing of products to meet or exceed internal and customer requirements.
· Apply systemic problem-solving methodologies in identifying, communicating and resolving quality issues.
· Plans and conducts projects and assignments with technical responsibility or strategic input.
· Lead or support the application of quality engineering/compliance of projects of various functions and levels.
· Ensure continuous improvement of quality system and product quality through the implementation and maintenance of quality metrics and NCR/ CAPAs.
· Develop and maintain risk assessment and mitigation plans through Control Plans, FMEAs and other risk assessment tools.
· Provide expertise in cleanroom, sterilization, biocompatibility, packaging, shelf life validation and post-sterile product release. Lead failure investigations related to the above-mentioned areas.
· Maintain supplier quality program by working collaboratively with product and service suppliers. Activities include supplier performance evaluation, quality investigation, product testing and performing occasional onsite audits/ visits (traveling required).
· Operate more independently and occasionally writes training material and conducts training sessions on quality activities.
· Maintain an updated knowledge in the areas of Quality Assurance, Regulatory Compliance, Design Controls, Risk management and Statistical Techniques.
· Responsible for ensuring compliance with all Federal, State, local and company regulations, policies and procedures.
Education & Experience :
· B.S. degree in engineering or in a scientific discipline is required.
· 2-5 years of quality function experience in medical device industry.
· CQE certification preferred
· Strong technical writing and communication skills.
· Independent, team player and lead by example.
· Ability to multitask and complete deliverables on time.
· Ability to lead, represent or participate during quality system audit
· Ability to work in an office environment, CER and travel to supplier sites as required.
Job Type: Full-time