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Senior Specialist, MDCP Sr. Quality Engineer at Merck

Senior Specialist, MDCP Sr. Quality Engineer

Merck Indianapolis, IN Full-Time
**Job Description**

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

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 to ensure compliance with applicable Medical Device Regulations and internal of our Company requirements. In addition, the Sr. Quality Engineer (Medical Device/Combo Products) is responsible for program planning and execution of MDCP prospective or remediation projects.

**Position Responsibilities:**

+ 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 pace environment with changing priorities. Ability to work in a matrix organization and effective written and oral communicator.

**Education Minimum Requirement:**

+ Bachelor's degree in (Science or Engineering or associated fields) with a minimum of 5 years related experience OR a Master's degree (Science or Engineering or associated fields) and 3 years related experience OR a Ph.D. (Science or Engineering or associated fields) and 1 year of related experience. Advanced degrees may be used to reduce required experience.

**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) certifications are preferred

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.

**Who we are ...**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for ...**

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.

**NOTICE FOR INTERNAL APPLICANTS**

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.**

Current Employees apply HERE ([ Link removed ] - Click here to apply to Senior Specialist, MDCP Sr. Quality Engineer />
Current Contingent Workers apply HERE ([ Link removed ] - Click here to apply to Senior Specialist, MDCP Sr. Quality Engineer />
**US and Puerto Rico Residents Only:**

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here ([ Link removed ] - Click here to apply to Senior Specialist, MDCP Sr. Quality Engineer if you need an accommodation during the application or hiring process.

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

EEOC Know Your Rights ([ Link removed ] - Click here to apply to Senior Specialist, MDCP Sr. Quality Engineer />
EEOC GINA Supplement?

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected salary range:

$87,800.00 - $149,100.00

**Search Firm Representatives Please Read Carefully**

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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:**

25%

**Flexible Work Arrangements:**

Flex Time, Hybrid, Remote Work

**Shift:**

1st - Day

**Valid Driving License:**

**Hazardous Material(s):**

**Number of Openings:**

3

**Requisition ID:** R215036

Recommended Skills

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