Job Description
Position Overview - Basic Functions & Responsibility
As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing Controls and Device Supplier Management objectives and build QMS capabilities that touch every aspect of our business processes, systems, and data.
The Associate Director will collaborate and interact with cross-function teams to identify opportunities for improvement and tackle challenges, balancing effective operations with transformative initiatives. The Associate Director, Quality System & Compliance will lead efforts to establish early commercialization Purchasing Controls processes and integrate the Device Supplier Management activities across MDCP programs and product lifecycle. Activities include supplier qualification & evaluation, documenting and maintenance of supplier quality agreements, supplier performance monitoring and re-evaluation, participating in supplier audits, and addressing any quality and regulatory issues. This role aims to ensure compliance with MDCP current Good Manufacturing Practices (cGMPs), other Global Health Authority Regulations and our company's requirements while driving continuous improvement in Device Supplier Quality Management. Accountable for other Quality Programs, as assigned.
Primary Activities
Primary activities include, but are not limited to:
- Works on all purchasing control phases for MDCP suppliers: planning, supplier evaluations/audits, supplier selection/qualification, quality agreements, supplier monitoring and re-evaluation, maintenance, and sustainability.
- Develop and implement phase‑appropriate supplier controls for early commercialization to effectively support MDCP programs in Development.
- Supports Supplier Audits, as Medical Device SME.
- Partner with MDCP sites and internal stakeholders to support investigations related to supplier caused deviations and CAPAs.
- Integrate Purchasing Control Activities into Integrated Project Plan for each MDCP Program (with target dates) for execution.
- Support the development of our company's supplier device specification based on intended use and user needs which includes defining list of requirements needed to be specified to supplier (quality, technical, commercial, supply) - shelf life, critical attributes, essential performance requirements, etc.
- Collaborate with Procurement for Device components, medical devices, and MDCPs to ensure all cGMP Purchasing Controls requirements are compliant.
- Participates on our teams supporting MDCP cGMP and quality issues related to pure Medical Devices and the device constituent part of a Combination Product.
- Manage activities within electronic computer systems, e.g., Material Management Systems (SAP), Document Management Systems (Veeva Vault), Supplier Management Systems, etc.
- Support MDCP sites with new/revised QMS Quality Standards and/or Global Procedures.
- Perform related duties, as assigned.
Skills
- Preferred experience in the assessment of US FDA 21 CFR Part 4 and Part 820, EU MDR:2017/745, and ISO 13485:2016 for review of Quality Management System documents for the Quality Manual.
- Previous experience in Medical Device and/or Medical Device Combination Products E2E Supplier Quality Management activities and preferred supplier auditing experience.
- Must have strong knowledge of regulations listed above and be able to work in a team environment identifying gaps in the QMS documents.
- Working knowledge for the design, manufacture, packaging, purchasing, testing, release, storage, and distribution of medical devices and/or medical device combination products.
- Must be able to build relationships within a team environment.
- Experience using computer systems for Quality Management Systems.
- Must have working knowledge of regulatory expectations for the design, manufacture/packaging and distribution of medical devices or medical device combination products with experience in quality assurance or regulatory oversight of these products.
- Experience authoring, reviewing and approving Quality Management System documents.
- Solid organizational skills including attention to detail and multi-tasking skills.
- Effective people skills and ability to work collaboratively across diverse teams and networks, able to foster cooperation in others.
- Effective written and oral communicator, ability to speak up and contribute in a team forum.
Qualifications:
- B.S. and/or M.S degree in an appropriate Science or Engineering discipline with a minimum of 8 years of experience with in-depth knowledge of pharmaceutical, medical devices and/or medical devices and combination products with at least 4 years in Supplier Quality Management System/ Purchasing Controls and in managing external partners / suppliers.
**Required Skills: **
Adaptability, Combination Products, Design Controls, Detail-Oriented, Employee Training, GMP Auditing, GMP Compliance, GMP Guidelines, Good Manufacturing Practices (GMP), Influencing Skills, Manufacturing Processes, Medical Devices, Purchasing Management, Quality Management Systems (QMS), Regulatory Compliance, Risk Management, Strategic Planning, Supplier Quality Management, Supplier Relationship Management
**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
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$129,000.00 - $203,100.00
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:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
No
Job Posting End Date:
05/8/2026
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. **