Merck Senior Specialist, MDCP Sr. Quality Engineer in Boston, Massachusetts
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.
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.
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Under New York City, Colorado State, Washington State, and California State 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
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .
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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.
Flexible Work Arrangements:
Flex Time, Hybrid, Remote Work
1st - Day
Valid Driving License:
Requisition ID: R215036
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