Senior Design Assurance Quality Engineer - Kforce Inc.
Chelmsford, MA 01824
About the Job
- Review and approve verification and validation protocols and reports
- Participate in Change Control review and approval activities as required
- Provide technical guidance and oversight to Quality Engineers
- Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971
- Develop and implement quality plans
- Ensure post market surveillance reviews are conducted and reports documented according to schedule
- Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues
- Provide key quality trending information and data for Management Review and monthly KPI review, as applicable
- Represent quality interests and concerns on project teams
- Investigate causes of quality and yield problems identified in the field and throughout the manufacturing and testing processes
- Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as process validation, equipment, test methods, root cause analysis, risk mitigation, process improvement tools, sampling plans, etc.
- Provide support during regulatory audits and responses to government agency questions
Requirements:
- Bachelor's degree in Engineering or technical discipline required
- 5 years of medical device experience required
- Proficient with Microsoft Office Suite
- Familiarity with mechanical and electrical test equipment
- Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing
- Working knowledge of EN ISO 13485, ISO 14971 and FDA QSR for Medical Devices (Regulations)
- Ability to work in a fast-paced environment
- High energy problem solver capable of driving items to closure
- Excellent communication and interpersonal skills (verbal, written and presentation). Understands how to present information dependent on the level of the audience.
- Ability to effectively manage time, balance multiple task assignments and translate quality requirements into product specifications
- Understands basic applied statistics, statistical sampling plans and statistical process control
- Familiar with Minitab Statistical Analysis Software (or equivalent)
- English expert (preferred)
- 5% Travel is required, primarily during working hours
The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.
We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.
Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.
This job is not eligible for bonuses, incentives or commissions.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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