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Primary Talent Partners has a 10-month contract opening for a Quality Microbiologist with a large medical device manufacturing company located in Plymouth, MN.
Job Description:
This role will be a key team member of the *** Surgical Innovations in the EU-MDR remediation effort. The candidate will work in a fast pace environment and is expected to have optimal critical thinking skills and audit readiness mindset to succeed in this role.
Role Expectations:
Nice To Have:
CISS Certification
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
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Job Description:
This role will be a key team member of the *** Surgical Innovations in the EU-MDR remediation effort. The candidate will work in a fast pace environment and is expected to have optimal critical thinking skills and audit readiness mindset to succeed in this role.
Role Expectations:
- Understanding and / or experience with EUMDR regulation and the changes needed in medical devices to be compliant with new regulation
- Act as Voice of Quality function on deliverables needed to remediate products to EUMDR and provide guidance to other cross functional team members from Quality function point of view
Interpret guidance documents and ISO Standards and apply them to EUMDR remediation scope of *** Diabetes products. - Broad understanding of how medical devices are approved in European Union such as interactions with Notified Body’s, Quality system requirements.
- Existing familiarity or ability to quickly come up to speed with other changing medical device regulations in the Europe region such as U.K. and Switzerland
- Objective # 1 - Locate Sterilization Validation Documentation:
- The candidate will be given a list of product part numbers in scope for EU-MDR remediation. The candidate is expected to search within the multiple product life cycle management systems for each product part number on the EU-MDR list to locate validation documentation for sterile devices.
- The candidate will create a list of all sterilization validation documents found for each product part number on the EU-MDR list.
- Objective # 2 - Review Sterilization Validation Documentation:
- Once validation documentation has been located within product life cycle management system, review for compliance alignment to applicable International Standards (ISOs) and guidance documents.
- For sterile disposable products, review sterilization validation documentation against the requirements of applicable sterile method ISOs (ISO 11135, ISO 17665, ISO 11137, or ISO 14937)
- Objective # 3 – Close identified compliance gaps: For product part numbers with identified gaps
- For sterile product part numbers with identified compliance gaps in terminal sterilization, lead efforts to remediate gaps by planning, executing, and managing sterilization validations at contract sterilizers and laboratories. Includes protocol and report writing.
- Objective # 4 – Optimize EO sterilization validation for each product family to ensure gas concentration levels align with enterprise sterilization validation requirements: lead efforts by planning, executing, and managing sterilization validations at contract sterilizers and laboratories. Includes protocol and report writing.
- 4+ years applied experience in radiation sterilization and ethylene oxide sterilization, specifically execution of validations
- Environmental Monitoring (EM) subject matter expertise.
- Ability to multi-task, Skilled in planning, organizing, coordinating projects and working independently
- Thorough familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices.
- Solid understanding of different types of sterilization methods (EtO, gamma, steam, etc.) including processes and equipment.
- Proven leadership and knowledge in international and national standards such as AAMI/ANSI standards, E-Beam, ISO 17665 (Steam), 11137 (Radiation), 11135 (EtO) and others as applicable (i.e. EN). Specifically, Ethylene Oxide.
- Excellent organizational and judgment skills. Ability to maintain and generate accurate records. Strong written, verbal communication skills.
- Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
40 hours per week
Nice To Have:
CISS Certification
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
#PTPJobs
