Senior Quality Engineer - Birmingham AL
The Role
The Senior Quality Engineer in our Birmingham, AL location develops, maintains and improves the quality system in accordance with the requirements of ISO, FDA QSR and STERIS policies. The responsibilities include quality planning in support of new product development, product quality improvement, complaint and CAPA management, supplier quality management, production and process controls, and continuous improvement through the use of statistical techniques and other accepted quality practices.
The Senior Quality Engineer plans and directs activities concerned with development, implementation, maintenance, and continuous improvement of our (QMS) quality system.
What You Will Do
• Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer.
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis.
• Initiate and/or participate in process and product corrective actions and problem-solving activities.
• Constantly review the current quality system and recommend / implement improvements as needed.
• Review collected data to perform statistical analysis and recommend process / product changes to improve quality.
What You Will Also Do
• Report on the performance of the quality system.
• Participate in strategic planning and audits of internal and supplier quality systems.
• Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Interface with various other departments and facilities within the company on quality related issues.
• Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
What You Will Need to Be Successful
• Bachelor's Degree required preferably in Engineering or Technology related.
• 6-10 years combined Manufacturing Engineering and/or Quality Systems experience with a focus on Design Control and CAPA.
• Medical Device or other regulated industry experience required.
• Excellent problem-solving skills.
• Experience working on cross-functional teams.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word and PowerPoint.
Preferred Experience
• ASQ, QSR, or AAMI certification, is desired.
• Advanced degrees or Quality Certifications are also desirable: CQE, CQA, CQMgr., Six Sigma or Lean
• Familiarity with QSR/GMP regulations desired.
• Process Validation experience desired.
• Experience with statistical analysis software desired
What STERIS Will Offer You
The opportunity to join a company that will invest in you for the long-term. STERIS couldn't be where it is today without our incredible people. That's why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal.
We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.
#LI-MO1
=== Company description
STERIS is a leading provider of infection prevention and procedural products and services, focused primarily on the critical markets of healthcare, pharmaceutical and research and medical devices. Our mission is to help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
We have 12,000 employees worldwide, with over 3,000 in Customer-facing sales and service roles. Founded as Innovative Medical Technologies in Ohio in 1985, the company was renamed STERIS in 1987. Many of the businesses that have been acquired and integrated into STERIS have much longer operating histories, notably the American Sterilizer Company founded in 1894.
The STERIS Vision is inspired by our Customers' efforts to create a healthier and safer world, and guided by our legacy of leadership and innovation; we strive to be a Great Company. To STERIS, this means we will make a difference by providing world-class product and service solutions for our Customers, safe and rewarding work for our People, and superior returns for our Shareholders.
The Senior Quality Engineer in our Birmingham, AL location develops, maintains and improves the quality system in accordance with the requirements of ISO, FDA QSR and STERIS policies. The responsibilities include quality planning in support of new product development, product quality improvement, complaint and CAPA management, supplier quality management, production and process controls, and continuous improvement through the use of statistical techniques and other accepted quality practices.
The Senior Quality Engineer plans and directs activities concerned with development, implementation, maintenance, and continuous improvement of our (QMS) quality system.
What You Will Do
• Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer.
• Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis.
• Initiate and/or participate in process and product corrective actions and problem-solving activities.
• Constantly review the current quality system and recommend / implement improvements as needed.
• Review collected data to perform statistical analysis and recommend process / product changes to improve quality.
What You Will Also Do
• Report on the performance of the quality system.
• Participate in strategic planning and audits of internal and supplier quality systems.
• Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Interface with various other departments and facilities within the company on quality related issues.
• Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
What You Will Need to Be Successful
• Bachelor's Degree required preferably in Engineering or Technology related.
• 6-10 years combined Manufacturing Engineering and/or Quality Systems experience with a focus on Design Control and CAPA.
• Medical Device or other regulated industry experience required.
• Excellent problem-solving skills.
• Experience working on cross-functional teams.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word and PowerPoint.
Preferred Experience
• ASQ, QSR, or AAMI certification, is desired.
• Advanced degrees or Quality Certifications are also desirable: CQE, CQA, CQMgr., Six Sigma or Lean
• Familiarity with QSR/GMP regulations desired.
• Process Validation experience desired.
• Experience with statistical analysis software desired
What STERIS Will Offer You
The opportunity to join a company that will invest in you for the long-term. STERIS couldn't be where it is today without our incredible people. That's why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal.
We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid time off, holidays, matching 401(k), annual merit, and incentive plans. Join us and help write our next chapter.
#LI-MO1
=== Company description
STERIS is a leading provider of infection prevention and procedural products and services, focused primarily on the critical markets of healthcare, pharmaceutical and research and medical devices. Our mission is to help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
We have 12,000 employees worldwide, with over 3,000 in Customer-facing sales and service roles. Founded as Innovative Medical Technologies in Ohio in 1985, the company was renamed STERIS in 1987. Many of the businesses that have been acquired and integrated into STERIS have much longer operating histories, notably the American Sterilizer Company founded in 1894.
The STERIS Vision is inspired by our Customers' efforts to create a healthier and safer world, and guided by our legacy of leadership and innovation; we strive to be a Great Company. To STERIS, this means we will make a difference by providing world-class product and service solutions for our Customers, safe and rewarding work for our People, and superior returns for our Shareholders.
Don’t miss out on new job openings!
Create a job alert for: Research Engineer, Birmingham
It's free, and you can cancel email updates at any time