Senior Quality Engineer

Manages processes and leads projects to maintain and improve the quality system in accordance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable standards.

Responsibilities

• Serves 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.
• Leads process and product corrective actions and problem-solving activities.
• Reviews the current quality system and recommends/implements 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 supplier audits and corrective actions.
• 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.
• 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.

Requirements

• Bachelor's Degree in Engineering.
• Minimum of 5 years of related experience (Manufacturing/Quality Engineering and/or Quality Systems).
• 5+ 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 to local supplier sites up to 10%-20%.

Preferred Qualifications

• ASQ, QSR Certification or familiarity with QSR/GMP regulations.
• Experience with statistical analysis software and Visio.
• Knowledge of Medical Device industry regulations such as ISO13485 and 21 CFR 820.
• QMS software (such as TrackWise or other QMS software system), SAP, or Oracle experience.

Schedule

This position requires working onsite in our Conroe, TX facility Monday through Friday during core business hours 7:30 am to 4:30 pm or 8:00 am to 5:00 pm.

Benefits

• 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
• Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

Pay

Pay range for this opportunity is $95,000 - $118,000. 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.