Microbiologist-Sterilization II

Medtronic • Fort Worth, TX

7d

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Join a world-class medical device manufacturing site in Fort Worth, Texas with Medtronic! At Medtronic Fort Worth, you will get to be on the cutting edge of spine surgery medical device manufacturing, ensuring the products for our patients are safe and free from contamination. At Medtronic, we put patients first, and in this role as Microbiologist Sterilization Specialist II, you will serve a critical function in that mission by ensuring the Fort Worth site’s cleanroom is compliant with both internal and external requirements, as well as ensuring product safety with product test review, data trending, audit support, and performing non-conformance investigations. Join a team of passionate microbiologists who each play a critical role in ensuring the parts we manufacture are safe and complaint. Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. Responsibilities may include the following and other duties may be assigned.

Requirements

• Requires a Bachelor Degree
• Requires a minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.

Nice To Haves

• Ability to assist in CAPA development, data trending, and risk assessments related to microbiology, sterilization, or process quality issues.
• Experience supporting or executing IQ/OQ/PQ activities for manufacturing equipment and controlled processes.
• Working knowledge of process capability analysis (Cp/Cpk), Gage R&R, and statistical sampling plans used in validating stable, capable production processes.
• Experience supporting nonconforming material investigations, root cause analysis, and determination of appropriate corrective/preventive actions.
• Strong analytical mindset with the ability to interpret data and recommend process or method improvements.
• CISS (AMI) Certification

Responsibilities

• Understand and implement policies that ensure compliance for controlled environments on-site in accordance with ISO 14644 series.
• Follow protocols and regulations in order to clean, store, and/or deliver products, supplies, and/or instruments, as well as support review of sterilization parameters for release.
• Interpret and evaluate the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
• Perform review of microbiology laboratory tests and ensure product families are appropriately tested at set frequencies.
• Develop, validate, and implement controlled environmental methods and overall site contamination control.
• Apply existing techniques and procedures with recommendations and implementation of modification for improved efficiency, or devise and develop new analytical methods and techniques.
• Prepare for internal and external audits and ensure manufacturing areas are compliant with internal work instructions. This includes auditing production and periodic assessment of internal processes.
• Perform corrective and preventative actions to support manufacturing nonconformances and close gaps from audits.
• Prepare samples for the execution of test protocols
• Support change control of internal work instructions and policies to align with industry best practices.
• May also be involved in establishing requirements for the transfer of methodology from R&D.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level