Job Information
Sterling Medical Devices Quality Specialist in Lenexa, Kansas
We are a cutting-edge medical device design and manufacturing firm located in the Kansas City metropolitan area. Our Company partners with companies world-wide to design and manufacture life-saving medical devices to be sold into the healthcare marketplace. Our culture is innovative, supportive, and focused on delivering the best medical devices to our clients. We are searching for a Quality Specialist to join our team.
The person we seek is detail oriented, focused, and enjoys tackling challenges. The ideal candidate has QA experience in the medical device field, or an equivalent regulated environment. This position requires demonstrated organization and communication skills as well as a desire to continuously learn and engage with cross functional teams and clients. You will be working with our team to inspect products, ensure we maintain accurate electronic and paper quality assurance files, and increase the effectiveness and efficiency of our processes through continuous improvement projects. Our focus on producing life-saving devices requires someone with a proactive approach, who believes in commitment, and enjoys working with a great team to achieve exceptional results.
Duties and Responsibilities:
Inspect product and/or materials to ensure adherence to specifications
Review documents for accuracy and compliance to regulations
Work collaboratively to prevent and resolve discovered issues in production
Document and effectively communicate findings and results of inspection to internal and external stakeholders
Work with Manufacturing and Design teams to ensure compliance to Company processes and Quality system
Review and analyze QA metric data, to report results and identify areas for improvement
Improve and innovate new processes and tools to support planned growth while maintaining quality levels
Assist Quality Manager with client and/or FDA quality requirements
Maintain electronic and paper QA files
Support internal and/or supplier audits
Qualifications:
Education – High School diploma required. An Associate's or Bachelor's degree preferred, or equivalent experience
Competency in the accountabilities above as demonstrated through education, training and accomplishments
Technical proficiency in quality assurance techniques and best practices
Exceptional attention to detail, prioritization, problem solving and organization skills
Experience in a regulated QA environment; preferably with FDA QSR, ISO 13485 and/or 9001 experience
Excellent verbal and written communication, interpersonal, planning, judgment, decision-making, risk management, and analysis skills.
Demonstrated ability to learn quickly and apply new concepts
We offer great benefits, competitive salary, and generous paid time off.
We are a cutting-edge medical device design firm located in the Kansas City metropolitan area. We partner with OEM companies worldwide to design and manufacture life-saving medical devices to be sold into the healthcare marketplace. Our culture is innovative, supportive, and focused on delivering the best medical device design and manufacturing services to their clients world-wide.
Our project list continues to grow and evolve into new therapeutic areas every year. In 2024 we will be developing new products for the treatment of:
Heart Failure
Cancer
Stroke
Gene Therapy
COPD
Traumatic Brain Injury
Atrial Fibrillation
Rhinitis
Back and Neck Pain
Blood Clots
Brain Surgery
+More!
We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide. If this is something you aspire to, we would like to talk with you!
Our Company values a diverse team and is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. All applicants must be authorized for full-time employment in the United States. For more information, visit www.rbccorp.com.
Local candidates only at this time, please. We do not offer relocation assistance.
No third-party candidates please.
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