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Microbiologist (Maternity leave replacement)

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Research & Development
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19000FRE Requisition #
Careers that Change Lives
Bring your talents to a leader in medical technology and healthcare solutions.  Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentorship, and guidance you need to own your future success. Join us for a career that changes lives.

A Day in the Life
Medtronic is among the world's largest medical technology, services and solutions companies. Our quality department is looking for a microbiologist with relevant experience and a positive proactive attitude to join our quality manufacturing team. This individual will work under the supervision of the Quality Manufacturing Manager. providing microbiology expertise and oversight for all products produced in all controlled environments at our site's cleanroom. The candidate must possess strong organizational skills and be able to effectively communicate with all levels of employees including a variety of internal and occasionally external individuals. This role requires a solid level of professionalism and responsiveness to business stakeholders in a large, dynamic and fast-paced environment.

 

Responsibilities may include the following and other duties may be assigned.

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  • Manages all requirements for controlled environments/clean rooms. 
  • Manages local bioburden programs and sterilization programs.
  • Provides in-depth microbiology technical support for sterile products manufacturing and aseptic processes.
  • Provides process development and equipment validation activity support including utilizing internal and external laboratory resources.
  • Provides leadership and direction for all microbiological / sterilization  validation protocol development and execution.
  • Supports day-to-day Microbiology Laboratory functions and initiatives including staffing, sample processing and quality control of test methods. 
  • Provides continued technical support with compliance activities including internal / external audits.
  • Develops and revises standard operating procedures (SOPs) for the local business unit as well as participating in global technical standards and guidance documents on microbiological methods and sterilization.
  • Leads site and laboratory microbiological investigations including root cause analysis.
  • Influence teams to drive consistency of microbiological practices across the site.
  • Helps prepare training materials to support a company culture of quality and compliance with focus on contamination control and aseptic process techniques.
  • Interacts with site and corporate management teams.
  • Compiles and presents microbiological data to site senior management and regulatory authorities in a concise and informative manner as needed.
  • Provides technical support and review for site change control documents and product or component specifications.
  • Participates in supplier quality audits as a microbiology SME for outsourced testing.
  • Recommends and implements policy changes to establish effective and efficient processes.
  • Identify potential issues and offer and negotiate solutions. 
Must Have: Minimum Requirements
  • Bachelors degree required
  • Minimum of 2 years of relevant experience
  • Bilingual (French/English)

Nice to Have
  • Excellent oral and written communication skills required. 
  • Knowledge of product release for an FDA/ISO compliant Quality System, and international Medical Device Regulations.
  • Possesses in-depth knowledge of FDA, ISO, GMP and GLP medical device requirements. Understanding of microbiology sterilization principles including is required.
  • Proficiency in use of Microsoft Office computer software, excel, power point.
  • Knowledge of SAP and TrackWise or related applications will be an asset.
  • Excellent documentation, communication, organization and prioritization skills.
  • Excellent interpersonal skills.
  • High degree of initiative.
  • Ability to problem-solve within a regulatory framework, meet deadlines, respond to and resolve issues in a timely manner.


About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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