Quality Engineer II
About The Position
The Quality Engineer II in our Conroe, TX location is responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role supports complaint/CAPA investigations, supplier quality improvement, operations production and process controls, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. This position requires working onsite in our Conroe, TX location between the hours of 7:30am to 4:00pm or 8am to 5pm.
Requirements
- Bachelor's Degree in Engineering.
- Minimum of 3 years of related experience (Manufacturing/Quality Engineering and/or Quality Systems), required.
- Minimum of 3 years of experience working in an ISO certified environment.
- Ability to travel domestically 10 %- 20%.
Nice To Haves
- ASQ, QSR Certification or familiarity with QSR/GMP regulations preferred.
- Experience with statistical analysis software and Visio, preferred.
- Knowledge of medical device industry standards ISO 13485 and FDA 21 CFR Part 820/211 preferred.
- QMS software (such as TrackWise or other QMS software system), SAP or Oracle experience, preferred.
Responsibilities
- Participate in cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
- Develop and implement statistically valid sampling plans, design experiments, capability studies, SPC and trend analysis.
- Initiate and/or participate in process and product corrective actions and problem-solving activities.
- Update/establish documented work instructions as needed.
- Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
- Monitor and report on performance metrics.
- Instruct other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
- Collaborate with 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.
- Perform supplier audits and quality system audits; provide guidance on corrective actions.
- Perform other duties as assigned
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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
