Sr. Sterilization Scientist

Overview

About QTS

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com.

Responsibilities

Sr. Sterilization Scientist Ideal Candidate Profile

QTS is currently seeking an energetic, responsive and well-organized full-time Sr. Sterilization Scientist.  This position will be responsible for providing leadership in setting and executing strategic initiatives related to microbiological quality and sterility assurance. This position performs work that is highly independent and focuses on advanced projects across all sterilization modalities. This function directly assists customer project engineering with validations, ongoing monitoring, and re-qualification activities. This position interacts and coordinates activities per the company’s quality systems procedure and adheres to FDA, GMP, and ISO regulations.

Sr. Sterilization Scientist Job Summary

• Act as the primary Sterilization Scientist resource for a large variety and number of customers.
• Provide work direction to the Sterilization Scientists I, II, and III.
• Responsible for training others in subjects related to microbiological quality and sterility assurance.
• Responsible for ensuring practices and procedures related to microbiological quality and sterility assurance comply with national and international standards and regulatory requirements.
• Research and development of initial sterilization validation plan for new devices and processes.
• Study product characteristics or customer requirements and confer with project engineering to determine validation objectives and standards.
• Prepare validation or performance qualification protocols for new or modified manufacturing processes.
• Draw samples of raw materials or intermediate and finished products for validation testing.
• Oversee outside testing and analytical service providers and interpret the subsequent data.
• Write validation and other study reports.
• Oversee routine audit and revalidation of existing cycles.
• Provide price estimates and/or quotations for engineering validation work to sales.
• Create validation protocols and reports.
• Maintain QTS procedures for compliance with appropriate standards and regulations.
• Resource for development and maintenance of environmental monitoring procedures, qualification, and validation.
• Complete investigation and resolution of sterilization or cleaning-related issues and anomalies.
• Actively involved in external professional groups (e.g. standards bodies), industry collaboration work, etc.
• Support internal and supplier audits.
• Support and comply with the company Quality System, ISO, and medical device requirements.

Qualifications

Sr. Sterilization Scientist Skills and Experience

• Bachelor’s degree in Biology, Microbiology, or related field.
• 7-10 years of experience in a related field.
• Microbiology as applicable to medical device sterilization.
• Familiarity with applicable AAMI, ASTM, and ISO standards related to medical device sterilization, cleaning.
• Knowledge of statistical methods.
• Technical writing for a variety of internal and external clients.
• Statistical Process control software.
• Familiar with medical device biocompatibility testing.
• Familiar with cleaning processes.
• Familiar with cleanroom manufacturing practices and standards.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective verbal and written communication skills.
• Great attention to detail and organizational skills.
• Ability to work in a fast-paced team environment.
• Ability to prioritize and multitask.

Desirable Skills and Experience

• Master’s degree in Biology, Microbiology, or related field.
• Certified Industrial Sterilization Specialist (CISS) Certifications.
• NRCM-SM and/or NRCM-RM Certification.

What Is It Like to Work for QTS?

At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment.  Here are some of things that employees have said about working at QTS:

• “I would describe my coworkers as kind and friendly.”

• “… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good fun ride so far and I can’t wait to keep it going!”

• “Three words that I would use to describe QTS’s culture are: Respectful, Fast-paced, and Fun!”

We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member.

Pay Range

Company Benefits

All Employees:

Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees. 

20 hours:

Cretex’s medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20 hours/week. 

30 hours:

Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30 hours per week. 

(Some benefits are subject to eligibility criteria.)

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.  

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify. 

Salary : $97,900 - $122,400