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 support to 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.
• 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.
• Leads Quality/Compliance Risk Assessments including Quality Risk Management Plans, mitigation action plans (incoming inspection and final assembly processes) for MDCP suppliers.
• 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. 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.

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.

Requirements

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.”

Salary Information

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US Salary Range

$126,500.00 - $199,100.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

25%

Flexible Work Arrangements

Remote

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

No

Job Posting End Date

05/13/2025

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.

Requisition ID:

R348304