Associate Director, Device Quality (Medical Devices)
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Reporting to the 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 employees. Activities will include developing, documenting, and review of documentation to ensure compliance with applicable Medical Device Regulations and internal Merck requirements.
In addition, the MDCP Quality Associate Director is responsible for program planning and execution of MDCP projects.
Primary Responsibilities include:
•Providing guidance on medical device design controls requirements to product development teams and cross functional team members.
•Contribute towards the development of retrospective and prospective Design History Files
•Support development of Device Risk Management as needed.
•Participates on Merck teams supporting MDCP CGMP and quality issues related to pure medical devices and the device constituent of a combination product.
•Works with the External and Internal Partners to ensure that effective and robust MDCP Quality Systems and Quality management are in place.
•Provides proactive support in training and coaching assigned sites to initiate quality improvements within Development, Operations and Quality.
•Audits and approves DHF (design history file) documentation for applicable regulatory filings, clinical supply, development and design transfer qualification. Ensure compliance with regulatory and Merck requirements. Evaluate deficiencies and assess impact on compliance status.
•Contributes to developing/revising policy and procedures for MDCP Quality and /or supported areas as needed.
•Supports preparations for regulatory agency inspections with focus on relevant MDCP regulations and Quality system requirements.
•Remains informed of current GMP requirements and industry trends as described in worldwide regulations and industry standards.
Yourrole at Merck is integral to helping the world meet new breakthroughs thataffect generations to come, and we’re counting on your skills and inventivenessto help make meaningful contributions to global medical advancement. At Merck,we’re inventing for life.Education Minimum Requirement:
- A Bachelor’s degree in (Science orEngineering or associated fields) with a minimum of 6 years related experienceOR a Master’s degree (Science or Engineering or associated fields) and 4 yearsrelated experience OR a Ph.D. (Science or Engineering or associated fields) and 2 years of related experience. Advanced degrees may be used reduce requiredexperience.
Required Experience and Skills:
- Led and managed development of DHF(design history file) deliverables for medical devices.
- Extensive knowledge of applicablemedical device regulations (21CFR820, MDD, ISO 13485)
- Demonstrated ability to work effectivelyin teams.
- Effective interpersonal skills andability to work collaboratively across diverse teams and networks; able to fostercooperation in others.
- Risk Management Experience (ISO 14971:2012)
- Ability to work in a matrixorganization.
- Effective written and oralcommunicator.
- Able to apply prior experiences andlearning in new settings, even if these are unfamiliar.
Preferred Experience and Skills:
- Remediation experience is desired.
- Knowledge of current GMPs forcombination products.
- QA/Regulatory Affairs Experience isdesired.
- ASQ (American Society for Quality) certifications are preferred.
If you need an accommodation for the application processplease email us at firstname.lastname@example.org.Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicitedassistance from search firms for this employment opportunity. Please, nophone calls or emails. All resumes submitted by search firms to anyemployee at Merck via email, the Internet or in any form and/or method withouta valid written search agreement in place for this position will be deemed thesole property of Merck. No fee will be paid in the event the candidate ishired by Merck as a result of the referral or through other means.Visa sponsorship is not available for this position.
For more information about personal rights under EqualEmployment Opportunity, visit:EEOC Poster EEOC GINA Supplement
Job: Qual Assurance & Ops Generic
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck