Sr. Specialist, Medical Device and Combination Product Quality

Company: Organon & Co.
Location: Olympia
Posted on: August 3, 2022

Job Description:

**Job Description**

Organon is a Women's Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women's health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It's going to be an exciting future-come be a part of it!

Reporting to the Associate Director, Medical Device and Combination Product (MDCP) Quality, the incumbent will be responsible for independent support of development and commercialization of Medical Devices including the device constituent part of Combination Products. This position will interact with cross functional teams working with all levels of the organization. Activities will include developing, documenting, and review of documentation related to but not limited to post market surveillance (Complaints, Deviations, Change control, etc.,), clinical development, etc. to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. In addition, the Sr. Quality Engineer (Medical Device/Combo Products) is responsible for program planning and execution of MDCP prospective or remediation projects.

This post can be 100% remote.

**Primary Responsibilities:**

• Provide guidance on medical device design controls requirements to product development teams and cross functional team members as needed.
• Contribute towards the development of Design History Files.
• Support development of Device Risk Management as needed.
• Participate on Organon teams supporting MDCP CGMP and quality issues related to pure medical devices and the device constituent of a combination product.
• Work with the External and Internal Partners to ensure that effective and robust MDCP Quality Systems and Quality management are in place.
• Provide proactive support in training and coaching assigned sites to initiate quality improvements within Development, Operations and Quality.
• Audit and approve DHF (Design History File) documentation for applicable regulatory filings, clinical supply, development and design transfer qualification.
• Ensure compliance with regulatory and Organon requirements. Evaluate deficiencies and assess impact on compliance status.
• Contribute to developing/revising policy and procedures for MDCP Quality and /or supported areas as needed.
• Support preparations for regulatory agency inspections with focus on relevant MDCP regulations and Quality system requirements.
• Remain informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards.
• Support the development of DHF (design history file) deliverables for medical devices and combination product.
• Support post market surveillance activities such as Change Controls, Deviations, complaints, etc.
  **Education Minimum Requirements:**
  
  + Bachelor's degree in (Science or Engineering).
  
  **Required Experience and Skills:**
  
  
  • 3 to 5 years of related experience in Medical Device or Combination Product.
  • Extensive knowledge of applicable medical device regulations (21CFR820, MDR, ISO 13485:2016).
  • Risk Management Experience (ISO 14971:2019).
  • Demonstrate the ability to work effectively in teams.
  • Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
  • A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
  • Must be a technical expert, and have excellent interpersonal relationship skills.
  • Flexibility to adapt to fast pace environment with changing priorities.
  • Ability to work in a matrix organization and effective written and oral communicator.
    **Preferred Experience and Skills:**
    
    
    • Remediation experience is desired.
    • Knowledge of current GMPs for combination products.
    • Regulatory Affairs Experience is desired.
    • Certified Lean Six Sigma Green Belt or Black Belt or ASQ (American Society for Quality) or equivalent certifications.
      **Who We Are:**
      
      Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
      
      Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.
      
      **Residents of Colorado:** to request this role's pay range: email: coloradopayact@organon.com
      
      Jersey City and New York City Positions: to request this role's pay range and benefits, email: **jcnycpayact@organon.com**
      
      **US and PR Residents Only**
      
      If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .
      
      For more information about personal rights under Equal Employment Opportunity, visit:
      
      EEOC Poster
      
      EEOC GINA Supplement
      
      OFCCP EEO Supplement
      
      OFCCP Pay Transparency Rule
      
      Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
      
      **Search Firm Representatives Please Read Carefully**
      
      Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
      
      **Employee Status:**
      
      Regular
      
      **Relocation:**
      
      No relocation
      
      **VISA Sponsorship:**
      
      No
      
      **Travel Requirements:**
      
      10%
      
      
      • *Flexible Work Arrangements:**
      • *Shift:**
      • *Valid Driving License:**
      • *Hazardous Material(s):**
      • *Number of Openings:**
        1
        
        **Requisition ID:** R510933
        

Keywords: Organon & Co., Olympia , Sr. Specialist, Medical Device and Combination Product Quality, Healthcare , Olympia, Washington