Quality Systems Specialist
2 weeks ago
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 SummaryThe 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 a weekend shift. Friday - Sunday; 6:00am-6:00pm.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.The Experience, Skills and Abilities Needed Required: Associate degree Minimum two (2) years experience in quality in a regulated industry ( FDA/ISO 13485). PC experience and working familiarity with MS application such as Word, Excel, Outlook and Teams. What STERIS Offers 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 #LI-KL1Pay range for this opportunity is $58,012.50 - $71,662.50. 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. 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.
-
Senior Quality Systems Specialist
2 weeks ago
Mentor, United States STERIS Full timeAt 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 SummaryThe Senior 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...
-
Quality Assurance Specialist
6 days ago
Mentor, Ohio, United States Mach10 Solutions Full time $60,000 - $80,000 per yearAbout the RoleAs a Quality Assurance Specialist, you will play a critical role in ensuring the reliability and quality of our products through meticulous inspection and data analysis. Your expertise in interpreting technical documents and applying statistical methods will directly contribute to maintaining high standards. You'll use your skills in GD&T and...
-
Divisional Quality Systems Engineer
2 weeks ago
Mentor, United States Avery Dennison Smartrac Full timeCompany DescriptionAvery Dennison Corporation (NYSE: AVY) is a global materials science and digital identification solutions company. We are Making Possible products and solutions that help advance the industries we serve, providing branding and information solutions that optimize labor and supply chain efficiency, reduce waste, advance sustainability,...
-
Quality Control Laboratory Specialist
4 days ago
Mentor, United States STERIS Full timeQuality Control Laboratory Specialist -2nd ShiftReq ID: 51388Job Category: QualityLocation: Mentor, OH, US, 44060 Workplace Type: OnsiteAt 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 QC Laboratory Specialistis...
-
Quality Control Laboratory Specialist
2 weeks ago
Mentor, OH, United States STERIS Full timeQuality Control Laboratory Specialist -2nd ShiftReq ID: 51388Job Category: QualityLocation: Mentor, OH, US, 44060 Workplace Type: OnsiteAt 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 QC Laboratory Specialistis...
-
Quality Control Laboratory Specialist
5 days ago
Mentor, OH, United States STERIS Full timeQuality Control Laboratory Specialist -2nd ShiftReq ID: 51388Job Category: QualityLocation: Mentor, OH, US, 44060 Workplace Type: OnsiteAt 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 QC Laboratory Specialistis...
-
Director of Quality
1 week ago
Mentor, Ohio, United States Race Winning Brands Full time $100,000 - $150,000 per yearRace Winning Brands (RWB) is the leading manufacturer of racing and high-performance parts sold to automotive and powersports markets. RWB is the preferred source for high-end pistons, engine blocks, cylinder heads, intake manifolds, connecting rods, crankshafts, clutches, transmissions, springs and other engine and driveline- related performance components....
-
Quality Inspector
5 days ago
Mentor, United States PPS-HPS Full timeJoin our dynamic team as an Inspection Technician, where you will play a crucial role in ensuring the highest quality standards in our manufacturing processes. You will utilize your keen eye for detail and expertise in quality control to perform inspections and tests on products, ensuring compliance with industry regulations such as ISO:9001 and AS9100...
-
Quality Engineer
2 weeks ago
Mentor, United States Precision Castparts Corp Full timeLocation Country: United States of America State / County: Ohio City: Mentor Division: Airfoils Company: Mentor/Painesville Function: Quality Workplace Type: On?Site Position Type: Full Time Opportunity ID: 19745 Company Profile With more than 120 operations and approximately 20,000 employees worldwide, Precision Castparts Corp. is the market leader in...
-
Benefits Specialist
2 weeks ago
Mentor, United States Crossroads Health Full timeBenefits Specialist Crossroads Health provides a continuum of quality life-changing behavioral health and specialized chemical dependency treatment services to children, adolescents, young adults, adults and families. As a leader in the behavioral health field, we offer a vast array of programs and services that evaluate, educate, strengthen and support...
