Quality Engineering Senior
$95k - $118kSTERIS
Senior Quality EngineerThe Senior Quality Engineer is responsible for managing processes and leading projects to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: This role leads complaint/CAPA investigations, supplier quality improvement actions, operations production and process control improvements, and product and service quality improvements with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.This position requires working onsite in our Conroe, TX facility Monday through Friday during core business hours 7:30 am to 4:30pm or 8:00am to 5:00pm.What You'll Do as a Senior Quality EngineerServes as the Core Team Member on cross-functional new product/service development teams with focus on the execution of quality plans and design/service transfer.Develops and implements statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis in support of products and service improvements.Reviews the current quality system and recommend / implement improvements as needed.Uses data to perform statistical analysis and recommend process / product changes to improve product and service quality.Leads projects focused on quality system, product quality and service quality improvements.Develops analyses and reports on the performance of the quality system.Leads and supports internal and external quality system audits.Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.Collaborates with other departments and facilities within the company on quality related issues.Supervises Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.The Experience, Skills and Abilities NeededRequired:Bachelor's Degree in Engineering.Manufacturing/Quality Engineering and/or Quality Systems).Experience with medical device or other regulated industries.Quality Management System Regulation FDA (QMSR) Certification or familiarity with QMSR/GMP regulations.Ability to travel to local supplier sites up to 10%- 20%.Experience with statistical analysis software and Visio preferred.Knowledge of Medical Device industry regulations such as ISO13485 and 21 CFR 820, preferred.QMS software (such as TrackWise or other QMS software system), SAP or Oracle experience, preferred.Generates alternatives and takes reasonable risks while solving technical problems.Generates detailed, high quality technical documentation to capture and communicate designs.Completes tasks on time with minimal supervision while identifying potential risks.What STERIS OffersWe value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future. Market Competitive payExtensive Paid Time Off and added HolidaysExcellent Healthcare, Dental and Vision benefitsLong- and Short-Term Disability coverage401(k) with a company matchMaternity and Paternity LeaveAdditional add- on benefits / discounts for programs such as Pet InsuranceTuition Reimbursement and continuing education programsExcellent opportunities for advancement in a stable long-term careerPay range for this opportunity is $95,000 - $118,000. This position is eligible for bonus participation.Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe.If you need assistance completing the application process, please call View phone number on click.appcast.io. This contact information is for accommodation inquiries only and cannot be used to check application status.STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location's HR Office during normal business hours.
$90k - $105k
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