What are the responsibilities and job description for the Sr. Quality Engineer, Ophthalmology position at Corza Medical?
Our mission
At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.
Our brand promise
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.
Job Purpose Summary
The Sr. Quality Engineer is responsible carrying out post-market surveillance activities that not only comply with all regulatory requirements but also contribute to the best possible experience for customers and patients. This role involves designing, building, and maintaining scalable data pipelines that facilitate continuous improvement in product quality and manufacturing processes.
What You Will Do
Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.
A reasonable estimate of the current pay range for this role is $100,000-$120,000/year salary. Further, pay is offered based on geographic location, internal equity, market data, applicant’s job-related skills, commensurate experience, required licensures, certifications, and certain degrees.
Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.
Notice To Third Party Agencies
Corza does not accept unsolicited resumes from recruiters, employment agencies, or other staffing services. Any unsolicited resumes, including those submitted to hiring managers or other business leaders, will become the property of Corza Medical and Corza Medical will have the right to hire that candidate without reservation – no fee or other compensation will be owed or paid to the recruiter, employment agency, or other staffing service.
At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience. We are here to support you every step of the way.
Our brand promise
We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.
- Remarkable service: A seamless, personal process designed around you and your needs.
- Trusted performance: Our product family is the result of years of experience championing surgeons and listening to their expertise.
- Outstanding value: No matter the surgical specialty, we deliver quality products for all markets.
Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.
Job Purpose Summary
The Sr. Quality Engineer is responsible carrying out post-market surveillance activities that not only comply with all regulatory requirements but also contribute to the best possible experience for customers and patients. This role involves designing, building, and maintaining scalable data pipelines that facilitate continuous improvement in product quality and manufacturing processes.
What You Will Do
- Perform post market compliance activities including customer complaint handling, adverse event reporting and medical device reports.
- Conduct preliminary investigation of complaints, including follow up with healthcare professionals.
- Initiate and support submittal of adverse event reports in an accurate and timely manner to the appropriate regulatory authorities within the required timeframe per applicable geography regulations.
- Collaborate with production, engineering, and other teams to investigate complaints and nonconformances, and contribute to manufacturing process-based improvement action.
- Implement preventive measures to minimize defects and non-conformances in manufacturing processes.
- Ensure compliance with industry standards, regulatory requirements, and quality management systems (e.g., ISO, FDA, GMP).
- Conduct regular audits and assessments to verify adherence to quality standards and procedures.
- Write, edit and approve process validation, engineering studies, and investigation reports.
- Promote and champion activities and initiatives aimed at improving the organization’s quality culture.
- Bachelor’s degree in engineering or equivalent combination of certification and work experience.
- 5 years of experience in medical device manufacturing environment.
- Must be able to speak fluent English, Spanish a plus.
- Proficient in Microsoft Office, statistical software programs, operating systems, etc.
- Experience in providing leadership to technical teams and the use of problem-solving methodologies such as DMAIC, Six-Sigma, etc.
- Strong understanding of statistics for Quality Assurance.
- High level of technical writing ability.
- Strong project management skills with an ability to work cross-functionally.
- ASQ Quality Engineer/Manager Certification preferred.
- Customer First - We deliver extraordinary experiences.
- Accountability - We do what we say.
- Integrity - We do what is right.
- Inspired - We love what we do.
- One Global Team -We before me, always.
Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.
A reasonable estimate of the current pay range for this role is $100,000-$120,000/year salary. Further, pay is offered based on geographic location, internal equity, market data, applicant’s job-related skills, commensurate experience, required licensures, certifications, and certain degrees.
Corza Medical is an equal opportunity employer. Corza Medical evaluates qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status or other protected characteristics.
Notice To Third Party Agencies
Corza does not accept unsolicited resumes from recruiters, employment agencies, or other staffing services. Any unsolicited resumes, including those submitted to hiring managers or other business leaders, will become the property of Corza Medical and Corza Medical will have the right to hire that candidate without reservation – no fee or other compensation will be owed or paid to the recruiter, employment agency, or other staffing service.
Salary : $100,000 - $120,000