This position requires working onsite in our Mentor, OH facility Monday through Friday.
Requires potential travel up to 10 % for training or to visit supplier or other STERIS sites both domestically and internationally (Mexico).
What You’ll do as an Advanced Quality Engineer
Leads the QMS integration of acquisitions or new manufacturing or service sites.
Leads production and process control integration and improvement for acquisitions and new manufacturing or service sites.
Leads Quality Management System design, implementation and improvement for new and existing manufacturing and service sites.
Designs and implements quality measurement systems and improvements for new and existing manufacturing and service sites.
Analyzes data and trends to ensure acceptance and effectiveness of site quality measurement systems.
Leads business-wide Quality Management System standardization initiatives.
Leads key manufacturing and service quality improvement initiatives and strategies.
Leads and executes the quality strategy for multiple manufacturing or service production lines.
Develops, implements, maintain and improves complex quality programs such as product and service quality, supplier controls and production/process controls.
Develops and generate reports and analyses on quality improvement initiatives to present to senior management.
Provides input to the annual Quality Planning Process.
Instructs other STERIS employees in quality principles, such as quality systems, problem solving, and valid statistical techniques.
Directs the work of Quality and other cross-functional staff in the execution of key projects and initiatives.
Perform all other duties as assigned.
The Experience, Skills and Abilities Needed
Required
Bachelor's Degree in Engineering, required.
Minimum of 8 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems).
Minimum of 8 years of experience working in an ISO certified environment.
Experience with medical device or other regulated industries.
Quality Management System Regulation FDA (QMSR) Certification or familiarity with QMSR/GMP regulations.
Ability to travel up to 10% for training or to go to supplier or other STERIS sites both domestically and internationally (Mexico).
Preferred
ASQ Certification, preferred.
Project Management skills and experience.
Experience with design transfer, process harmonization and sustainability.
Knowledge of Track Wise, Windchill PLM, or other similar systems.
Knowledge of ISO 13485 regulations.
Other
Shares technical knowledge with others in the team.
Identifies technical problems and provides innovative solutions.
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.
Drives improvements in processes for better efficiency.
Utilizes advanced tools and best practices to track product and process metrics.
Mentors team members on timely task completion and actively participates in brainstorming sessions.
What STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.
Here is just a brief overview of what we offer
Market Competitive pay
Extensive Paid Time Off and added Holidays
Excellent Healthcare, Dental and Vision benefits
Long- and Short-Term Disability coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add- on benefits / discounts for programs such as Pet Insurance
Tuition Reimbursement and continuing education programs
Excellent opportunities for advancement in a stable long-term career
#LI-MO1
#LI- Onsite
Pay range for this opportunity is $107,525 - $139,150. This position is eligible for bonus participation.
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. 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 offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits
Open until position is filled.
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. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
