Quality Systems Specialist

Position Summary The Quality Specialist in our Mentor, OH location 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 role requires working onsite in our Mentor, OH location Monday through Friday. What You'll do as a Quality 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: - Associates degree and a minimum of 2 years of experience in Quality in a regulated industry (i.e. FDA/ISO 13485). - In lieu of a degree, a high school diploma or GED and 6 years of experience in a regulated industry**.** Preferred: - Experience working in a manufacturing environment, preferred. - Previous Quality Specialist experience and a strong understanding of Quality Management Systems. - Strong interpersonal communication and collaboration skills (will work with training program). - Experience working with applications such as Trackwise or Windchill. - Knowledge of MS Office Suite applications including Excel and PowerPoint. Other: - Customer Focused: Demonstrates a "Customer first" mindset. Responds with a sense of urgency. - Teamwork: Collaborates with others. Works in a professional manner to support team actions. - Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities. - Communication: Constructs clear written communication. Keeps manager and co-workers informed. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future. Here is just a brief overview of what we offer: - 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 #LI-MO1 #LI- Onsite Pay range for this opportunity is $59,075 - $76,450. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates