What are the responsibilities and job description for the Quality Systems Specialist position at STERIS?
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 Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.
This position will support facilities in Mentor, OH and Franklin Park, IL. Based on business needs.
What You'll Do as a Quality Systems Specialist
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.
Here is a brief overview of what we offer:
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.
Position Summary
The Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process.
This position will support facilities in Mentor, OH and Franklin Park, IL. Based on business needs.
What You'll Do as a Quality Systems Specialist
- Complete document control transactions. Manage Customer complaint investigations and complete complaint documentation. Facilitate CAPA and NCR investigations and may coordinate investigation documentation. Review DHR’s and support batch record release. Manage record retention practices within the site. Manage site calibration activities and recordkeeping. Support site inspection activities and recordkeeping. Coordinate internal and external audits. Support supplier quality and Customer assessment activities. Track and trend site Quality data.
- Support targeted Lean activities. Complete other duties as assigned.
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.
Here is a brief overview of what we offer:
- Market Competitive Pay
- Extensive Paid Time Off and (9) added Holidays
- Excellent Healthcare, Dental and Vision Benefits
- Long/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 continued education programs
- Excellent opportunities for advancement in a stable long-term career
- Required:
- Associate Degree
- Minimum two (2) years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485). Will accept six (6) years of experience in a regualted industry without a degree.
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.
Salary : $52,250 - $69,500