Quality Specialist

<div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Position Summary</H2></div><div><p>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. </p><p> </p><p><strong>Will consider relocation for the right candidate.</strong></p><p> </p></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>What You'll Do as a Quality Specialist</H2></div><div><ul style="margin-bottom: 0in; margin-top: 0px;"><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Complete document control transactions.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Manage Customer complaint investigations and complete complaint documentation.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Facilitate CAPA and NCR investigations and may coordinate investigation documentation.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Review DHR’s and support batch record release.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Manage record retention practices within the site.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Manage site calibration activities and recordkeeping.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Support site inspection activities and recordkeeping.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Coordinate internal and external audits.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Support supplier quality and Customer assessment activities.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Track and trend site Quality data.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Support targeted Lean activities.</li><li style="line-height: 150%; margin: 0in 0in 0in 0px; font-size: 11pt; font-family: Aptos, sans-serif;">Complete other duties as assigned.</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>The Experience, Skills and Abilities Needed</H2></div><div><p><strong>Required:</strong></p><ul><li>Minimum six years experience in a regulated industry (i.e.

FDA/ISO 13485) in lieu of Associate degree.</li><li>Minimum two years experience in quality in regulated industry (i.e. FDA/ISO 13485) with Associate degree.</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>What STERIS Offers</H2></div><div><p>We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future.</p><p>Here is a brief overview of what we offer: </p><p>• Market Competitive Pay<br />• Extensive Paid Time Off and (9) added Holidays<br />• Excellent Healthcare, Dental and Vision Benefits<br />• Long/Short Term Disability Coverage<br />• 401(k) with a company match <br />• Maternity and Paternity Leave<br />• Additional add-on benefits/discounts for programs such as Pet Insurance<br />• Tuition Reimbursement and continued education programs<br />• Excellent opportunities for advancement in a stable long-term career</p><p><br /><br /></p></div></div></div> <p>Pay range for this opportunity if $62,000 - $74,000 per year.<span style="color:black"> This position is eligible for bonus participation.</span></p><p> </p><p>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.</p><p> </p><p>STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: <a href="https://steris-corp-comm.box.com/s/pgvfuqq6urrtkov891ypp1a7bvdvn2ta">STERIS Benefits</a></p><p> </p><p>Open until position is filled.</p><p> </p><p>STERIS