Quality Engineer II
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Job Location:
Plymouth, MA - USA
Monthly Salary:
$ 84362 - 109175
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
At STERIS we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
The Quality Engineer II 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 will be focused on and leading within the QMS space. This included mentoring others on the QMS processes/systems document control and audit support.
What Youll Do as a Quality Engineer II
- Participate on cross-functional new product development teams with focus on product/ service quality and Quality System compliance.
- 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.
- 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 quality system audits and provide guidance on corrective actions.
- Perform other duties as assigned.
The Experience Skills and Abilities Necessary
- Bachelors Degree in Engineering.
- Minimum of 3 years of related experience required. (Manufacturing/Quality Engineering and/or Quality Systems)
- 3 years of experience working in an ISO certified environment
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Pay range for this opportunity is$84362.50-$109175.00. 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.
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
STERIS is a leading provider of infection prevention and other procedural products and services. Learn more here.
