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Job Description

The Position

Reporting to the Director, Healthcare Products (HPQA), 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 to ensure compliance with applicable Medical Device Regulations and internal Organon requirements.

Sr. Quality Engineer (Medical Device/Combo Products) is responsible for program planning and execution of prospective or remediation projects.

This position will be the first contact support for external inspection support for Organon LLC and must work onsite within Organon’s Jersey City office.

Responsibilities

+ Provide guidance on medical device design controls requirements to product development teams and cross functional team members.

+ Contribute towards the development of Design History Files.

+ Support development of Device Risk Management as needed.

+ Participate on Organon teams supporting 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 Quality Systems 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.

+ Support preparations for regulatory agency inspections with focus on relevant device regulations and Quality system requirements.

+ Remain informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards

Required Education, Experience and Skills

+ Support the development of DHF (design history file) deliverables for medical devices.

+ Extensive knowledge of applicable medical device regulations (21CFR820, MDD, ISO 13485:2016), Risk Management Experience (ISO 14971:2012).

+ 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, work independently, and have excellent interpersonal relationship skills with flexibility to adapt to fast-paced 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 are preferred

Education/Experience minimum requirement:

+ A bachelor’s degree in (Science or Engineering or associated fields) with a minimum of 5 years related experience OR

+ Master’s degree (Science or Engineering or associated fields) and 3 years related experience OR

+ Ph.D. (Science or Engineering or associated fields) and 1 year of related experience. Advanced degrees may be used to reduce required experience if necessary skills/experience can be demonstrated

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.

US and PR Residents Only

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

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.

**Applicable to United States Positions Only:** Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$93,500.00 - $158,900.00

Please Note: Pay Ranges are Specific to local market and therefore vary from country to country

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:** **Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

**Requisition ID:** R532963