Address
Form of workJob Description
Description:
1. Understanding and / or experience with EUMDR regulation and the changes needed in medical devices to be compliant with new regulation
2. 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
3. Interpret guidance documents and ISO Standards and apply them to EUMDR remediation scope of Medtronic Diabetes products.
4. Broad understanding of how medical devices are approved in European Union such as interactions with Notified Bodyrsquos Quality system requirements.
5. 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
DESCRIPTION
- This role will be a key team member of the Medtronic 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:
- The Senior Microbiologist-Sterilization will be responsible for the sterility assurance EU-MDR remediation efforts by meeting the objectives detailed below:
- 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
*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- Prepare deficiency responses as needed for EU MDR submissions
* Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth typically obtained through advanced education combined with experience.
* May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience.
RESPONSIBILITIES:
**Analyzes chemical biological or microbiological products raw materials in process materials release test samples or stability samples in support of the company's quality program. Interprets and evaluates the analyses in terms of accuracy and precision compared against established specifications and recommends and implements corrective action where necessary.
**Develops validates and implements controlled environment methods. Applies existing techniques and procedures with recommendations and implementation of modification for improved efficiency or devises and develops new analytical methods and techniques.
**Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation. May also be involved in establishing requirements for the transfer of methodology.
OTHER JOB DUTIES:
** Typically an individual contributor with responsibility in a professional discipline or specialty.
** Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
**May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies using specialized knowledge and skills normally acquired through advanced education typically University.
DIFFERENTIATING FACTORS:
** Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions.
** Coaches and reviews the work of lower level specialists may manage projects / processes.
** Organizational Impact: May be responsible for entire projects or processes within job area.
** Contributes to the completion of work group objectives through building relationships and consensus to reach agreements on assignments.
** Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues job areas or specialties .
** Makes improvements of processes systems or products to enhance performance of the job area.
** Analysis provided is in depth in nature and often provides recommendations on process improvements.
** Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts statuses ideas and issues to achieve objective and influence decision making.
** Leadership and Talent Management: May provide guidance coaching and training to other employees within job area. May manage projects requiring delegation of work and review of others' work product .
Skills:
ISO11135, EO sterilization, ISO 11135, microbiology, sterilization, ehtylene oxide
Additional Skills & Qualifications:
** 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
** Education Required: Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience
** Years of Experience Required: Requires a University Degree and minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years relevant experience
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About ActalentActalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
