Job Description
Position Overview - Basic Functions & Responsibility Essential function(s) includes, but is not limited to:
Reporting to the Senior Director of Device Quality and Regulatory (DQ&R), the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support 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 maintenance of technical business solutions, reviewing and approving medical device/combination product documentation to support regulatory filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good Manufacturing ruling (21CFR part 4), Device Risk Management (ISO 14971) and other worldwide regulations and company requirements. This position provides Device quality engineering and quality assurance support and leadership to ensure successful quality oversight of prospective medical devices and medical device combination products.
Primary Activities Primary activities include, but are not limited to:
Skills
7 years of relevant work experience.
Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485).
Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
Risk Management experience (ISO 14971/24971, ICH Q9).
Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices.
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.
Ability to work in a matrix organization and effective written and oral communicator.
Preferred experience and skills:
Qualifications:
US based - NJ/PA or other US location
Travel - Yes, <10% of the time
Required Skills:
Clinical Quality Assurance, Clinical Quality Assurance, Combination Products, Computer System Validation (CSV), Design Thinking, Detail-Oriented, External Partners, GMP Compliance, Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Interpersonal Relationships, Leading Project Teams, Lean Six Sigma (LSS), Manufacturing Audits, Manufacturing Compliance, Material Specifications, Medical Device Management, Medical Device Regulations, Medical Devices, Product Development, Project Management, Quality Assurance (QA), Quality Control Management, Quality Improvement Programs, Quality Standards {+ 2 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
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 if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The salary range for this role is
$142,400.00 - $224,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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:
10%
Flexible Work Arrangements:
Remote
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
07/10/2026