Bachelor's degree in engineering, life sciences, or related field preferred
Minimum 4-6 years related experience in Quality Assurance within Medical Device or other regulated industry; or equivalent combination of education and experience
Strong understanding of Medical Device regulations (FDA 21CFR820 and ISO 13485)
Experience with quality management systems and associated processes
Quality certifications (e.g ASQ Certified Quality Auditor or Engineer) a plus.
Excellent analytical skills, able to solve complex problems and make data-driven decisions.
Effective communication and interpersonal skills with the ability to collaborate across functional teams
What you will be responsible for:
This position is responsible for supporting Quality Assurance processes; including but not limited to corrective/preventive action activities, batch record reviews, and change control, represent associated QA processes during internal and external audits, as needed. This position serves as QA delegated authority for the disposition of device history records, ensuring documentation is complete, accurate and demonstrates lots are manufactured in accordance with product specifications/requirements.
How you will contribute:
Reviews manufacturing and support records (Device History Records (DHR)) to ensure product specifications are met prior to final product disposition
Provides final QA disposition of DHR, including release of products based on acceptance of manufacturing and support records
Reviews proposed product and process changes initiated through the Change Review process for accuracy and completeness
Provides final QA disposition of recommended product and process changes initiated through the Change Review process
Works with Production and cross-functional teams to resolve issues resulting from record reviews
Conducts and supports investigation of non-conformances and identification of corrective and preventive actions, as needed
Develop and implement CAPA plans to address root causes to prevent recurrence
Serves as a team member for audits, including customer, internal and external (regulatory inspections) by assisting with document retrieval efforts, and other activities related to support a successful outcome.
Acts as a team member in supporting quality disciplines, decisions, and practices
Identify opportunities for process improvements and drive initiatives to enhance quality, efficiency, and effectiveness
Applies critical thinking, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Generate internal quality documentation such as quality plans, standard operating procedures, and inspection procedures.
Performs duties in an ethical and compliant manner, ensuring compliance to Medical Device global regulations, standards and company policies and procedures.
Provide training and support for responsible quality system processes, as needed.
Monitor and trend quality processes, initiate actions to resolve negative trend results. Report and escalate trends to management
Perform other job-related duties, as directed.
About Us - Medcomp® develops, manufactures, markets, and supports cutting-edge vascular access devices and accessories to meet the clinical needs of the medical industry, particularly in the fields of interventional medicine and dialysis. Our company's engineering and applications expertise provides superior products whose progressive designs accommodate advances in medicine and whose quality anticipates the requirements of our professional clients and the patients they serve. Currently one of the world's largest manufacturers of dialysis and centrally terminating venous catheters, Medcomp is, and always has been, on the cutting edge of new vascular access device technologies.
Our offerings have our Team Members’ well-being in mind.
Competitive compensation
Health, Dental, Vision coverage
FSA
Life Insurance
401k
Paid Holidays
Generous PTO
What you will get from us:
VISION & MISSION STATEMENT
To be the leading solution provider for every customer we serve.
To drive sustainable growth of our business through the continued investment in our people, technology and quality while delivering world class products and services.
We offer meaningful rewarding work to our team members by providing a culture that is built on and supported by practicing our core values, and by providing our team members with the tools and resources they need to succeed.
We are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.
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Seniority level
Entry level
Employment type
Full-time
Job function
Other
Industries
Internet Publishing
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