Senior Quality Systems Specialist - Mentor
2 days ago
Job description
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 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 Part 820/211, EU MDR and other applicable regulatory standards. This role manages document control transactions, site record retention, calibration and inspection activities. In addition, the Senior Quality Specialist will lead Customer complaint, CAPA and NCR investigations, manage site audit activities, support supplier quality and customer assessments and lead risk management activities where appropriate. This role may also track and trend Quality data and support a site's Management Review process.
What You'll Do as a Senior Quality Systems Specialist
- Manage the document control processes for the site.
- Lead Customer complaint investigations and ensure complete complaint documentation.
- Lead CAPA and NCR investigations and ensure proper documentation.
- Manage the DHR and batch record release process.
- Manage record retention practices within the site.
- Coordinate site calibration activities and recordkeeping.
- Manage site audit activities and recordkeeping.
- Support supplier quality and Customer assessment activities.
- Track, trend and analyze Quality data.
- Support targeted Lean activities.
- Complete other duties as assigned.
Required Experience
Required:
- Bachelor's degree required in related technical field (i.e. Engineering, Chemistry, Biology).
- Minimum five (5) years of experience in a regulated industry (i.e. FDA/ISO 13485)
- Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis)
- PC experience and working familiarity of common desktop applications including Excel and Word.
- Takes ownership of task and projects and seeks clarification if unsure of direction.
- Understands and can interpret appropriate regulatory standards.
- Ability to analyze and interpret data and use as input to problem solving.
Preferred:
- Certification: ASQ, QSR, or AAMI certification preferred.
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 with shift differential
• 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-KL1
Pay range for this opportunity is $78,200 - $96, 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.
Similar jobs
The Quality Systems Specialist role assists in administration of quality functions at a site to assure adherence to ISO standards. · ...
1 month ago
The Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001 and other regulatory standards. · ...
1 month ago
The Senior Quality Systems 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 and other applicable regulatory standards. · Manage the document control processes fo ...
3 days ago
The 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 Part 820/211, · EU MDR and other applicable regulatory standards.Manage the document control process ...
1 month ago
The 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 Part 820/211, EU MDR and other applicable regulatory standards. · ...
1 month ago
The Senior Quality Systems 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. ...
3 days ago
The System Integration Specialist is responsible for driving revenue on mechanical sales/service jobs and ensuring those jobs are completely to a high level of quality while enhancing profitability. · Liaise with all company departments, personnel and Mgmt. to meet role objective ...
1 month ago
This position involves analyzing military pay and financial data to identify discrepancies or issues in records and reports. · ...
3 weeks ago
+Job summary · We take pride in enabling sustainable progress through technology by empowering customers combining the real and digital worlds. · We know that the only way a business thrives is if our people are thriving.+ResponsibilitiesCommission new distributed digital control ...
1 month ago
Immediate opening for a Building Automation System Specialist that would be responsible for designing, implementing, testing and troubleshooting BAS systems to improve building performance, energy efficiency and occupant comfort. · ...
2 weeks ago
We take pride in enabling sustainable progress through technology. We do this through empowering customers by combining the real and digital worlds. · Our Smart Buildings help to create efficient, safe, adaptable, and responsible environments. Our aim isn't just about improving b ...
3 weeks ago
NWH seeks a qualified Application Systems Support Specialist to join their IT team. This position will focus on the development and support of internal and third-party applications to facilitate efficient data flow and operational continuity. · Actively monitor and address issues ...
2 weeks ago
This is a highly skilled position requiring advanced knowledge of distributed automation systems HVAC (Heating, Ventilation and Air Conditioning), communication networking, computer software, and electrical distribution. · Advanced knowledge of distributed automation systems HVAC ...
4 days ago
NWH is seeking a qualified Application Systems Support Specialist to join our IT team. This position will focus on the development and support of internal and third-party applications to facilitate efficient data flow and operational continuity. · Actively monitor and address iss ...
1 month ago
Eaton is seeking a Senior Specialist IT Systems Analyst to design and implement functional software solutions in SAP Sales and Distribution (SD). The ideal candidate will have hands-on expertise in SAP S/4HANA SD. · ...
1 week ago
Program building automation systems including HVAC lighting energy management controls. · Develop control logic sequences of operation graphics system documentation. · Commission troubleshoot BAS installations to ensure proper operation performance. · ...
2 weeks ago
Our client is seeking a technically skilled, business-minded HRIS Administrator to serve as the internal owner and power user of ADP Workforce Now. · ...
3 weeks ago
We are seeking a technically skilled, business-minded HRIS Administrator to serve as the internal owner and power user of ADP Workforce Now. · ...
3 weeks ago
As a RoviSys Building Technologies employee you will use the latest control and automation technologies as we provide innovative solutions for our clients. · ...
1 month ago
We are seeking an entry level systems engineer to join our team. · ...
1 month ago