Microbiologist-Steriliz Mgr

3 days left

Employer
Medtronic
Location
Brooklyn Park, Minnesota, US
Salary
Competitive
Posted
Jun 04, 2021
Closes
Jun 16, 2021
Ref
2209909674
Discipline
Project Management
Employment Type
Full time
Salary Type
Salary
Microbiologist-Steriliz Mgr
Location:
Brooklyn Park, Minnesota, United States
Requisition #:
21000DPP
Post Date:
May 24, 2021
Careers that Change Lives
A Day in the Life
Provide management of sterility assurance program and team within the Medtronic Cardiac Surgery operating unit across 5+ manufacturing sites. This position is responsible for organizing, planning managing personnel, systems, and resources to support all sterility assurance related needs for both in-house and contract manufacturing locations. The manager will Interface with diverse cross-functional team members and oversees sterilization control policies programs to assure that Medtronic MITG medical devices consistently comply with microbiological control requirements, standards, guidelines, and industry practices, both domestic and international.
Responsibilities may include the following and other duties may be assigned.
- Supports team in providing microbial technical expertise during new product development activities, process modification studies and failure investigations regarding sterility assurance. Ensures coordination across functional groups, contract laboratories and manufacturing sites.
- Provides oversight of the sterilization program; ensuring that validations and requalifications are compliant with all applicable international and domestic regulations and standards by defining policies, monitoring performance and conducting necessary related training.
- Conducts investigations regarding unacceptable requalification and sterilization processing, establishes corrective preventive actions to address, and reviews resulting outputs with Quality Management.
- Ensures sterilization facilities utilized are qualified and meet necessary requirements prior to use.
- Ensures facilities environmental monitoring / control program meets necessary requirements.
- Oversees develops employees within direct and indirect team.
- Communicates detailed information regarding required policies and monitoring results to Manufacturing and Quality Assurance Managers.
- Compile KPI data from various sources, establish trends, recommends revisions to monitoring program and/or manufacturing process controls.
- Ensures effective corrective actions are implemented, where necessary.
- Provides microbiological technical expertise to manufacturing facilities, cross functional teams and management.
- Assures timely, accurate evaluations of product compliance to sterilization and microbiology requirements.
- Provides oversight of sterilization initiatives feedback to management on performance, goals, and status.
- Supports other business units with sterilization initiatives as needed.
- Supports site(s) compliance of sterility assurance to notified bodies and internal/external audits.
- Supports Regulatory Affairs and other departments by providing technical input on sterilization and microbiology related content of regulatory submissions and departmental procedures.
- Functions as part of the site Quality Engineering team and supports other Quality System elements (such as CAPA or Nonconforming Material Reports) as needed.
- Willing for minimal travel with notice.
Must Have: Minimum Requirements
- Bachelors degree required
- Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience
Nice to Have
- Thorough familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization of medical devices.
- Solid understanding of different types of sterilization methods (EO, gamma, steam, etc.) including processes and equipment.
- Proven leadership and knowledge in international and national standards such as AAMI/ANSI standards, ISO 17665 (Steam), 11137 (Radiation), 11135 (EO) and others as applicable (i.e. EN)
- Proven management and interpersonal skills.
- Excellent organizational and judgment skills.
- Strong written, verbal communication skills.
- Degree in Microbiology, Chemistry, Engineering or similar field
- Certified microbiologist or Certified Industrial Sterilization Specialist
- 7+ years industrial microbiology experience in the Medical Device or Pharmaceutical industry
- Experience in ethylene oxide, radiation, and steam sterilization with direct knowledge of validation process controls and change control
- Knowledge of applicable
- ASTM,ISO, FDA and EN regulatory standards
- Exceptional problem solving skills, strong oral and written communications skills, and excellent interpersonal skills
- Strong people management capabilities and passion for developing and coaching talent
- Computer proficiency using word processors, spreadsheet, and project management
- Able to apply advanced scientific principles
- Good oral and written communication skills
- Excellent presentation skills
- Must be able to handle multiple tasks/projects and manage business unit priorities accordingly
- Must be able to lead in a team environment, including cross-functional teams, and exert influence without alienating others.
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. Lets 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)
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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