Specialist, Quality Systems & Compliance

Merck; West Point (PA); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work

Job summary

Merck is seeking a Specialist, Quality Systems & Compliance in Device Regulatory & Quality to support the MDCP Complaints team and related systems. You will engage cross-functionally to ensure compliance with medical device regulations and internal requirements, while executing MDCP projects and supporting device data across SAP and Veeva Vaults.

The role emphasizes review of complaints, data maintenance, and collaboration with QA, TO, and device teams to drive corrective actions and risk

Qualifications

• 1-3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.
• Bachelor’s degree in Science, Engineering, Health Care, STEM or related technical field
• Ability to work in a cross-functional environment and produce detailed technical writing

Responsibilities

• Review reportable external customer complaints, upon intake, for appropriateness for health authority submission
• Document review/approval in complaint database
• Collaborate with Site Complaint Investigating Unit and Device-Technical Operations to ensure root cause analysis considers device design and manufacturing factors
• Collaborate with Site Complaint Investigating Unit and Device to ensure robust corrective and preventive actions are implemented
• Review the Device Risk Management Files to ensure the customer complaint is accurately represented
• Collaborate with Device to update the Device Risk Management files, as needed
• Review and approve reportable external customer complaint investigation reports prior to submission to health authority
• Assist with maintenance of MDCP data across SAP ECC, SAP PLM, and Veeva Quality/R&V Vaults
• Coordinate, approve as Quality role all creations/changes to SAP master data field ZZMAT_MDCP_ID
• Submit SAP post-approval updates to GCM TW team for MDCP identifier updates
• Maintain SAP access and role mapping for Device Quality & Regulatory Complaints team
• Support LMS training system as steward
• Maintain team SharePoint sites
• Maintain MDCPQ mailbox and related activities
• Maintain metrics and reporting for MDCP deviations, changes, CAPAs and complaints

Skills

Adaptability

Teamwork

Problem Solving

Detail-oriented

Education

Bachelor's degree in Science/Engineering/Health Care/STEM

Tools

SAP ECC

SAP PLM

Veeva Vaults

Job description

Job Description

The Specialist, Quality Systems & Compliance in Device Regulatory & Quality, will be responsible for supporting MDCP Complaints team and other DQ&R Systems tasks and priorities as needed. This position will interact with cross-functional teams and sites. Activities will include review of documentation to ensure compliance with applicable Combination Product or Medical Device Regulations and internal of our company's requirements. In addition, the Specialist is responsible for execution of MDCP projects and support of the device data domain.

Primary Activities Include But Are Not Limited To

• Review reportable external customer complaints, upon intake, for appropriateness for health authority submission
• Document review/approval in complaint database
• Collaborate with the Site Complaint Investigating Unit and Device -Technical Operations (TO) to ensure the device and device components are adequately considered as part of the root cause analysis and to ensure the design of the device and device components are adequately considered when manufacturing or packaging root causes are not identified.
• Collaborate with Site Complaint Investigating Unit and Device to ensure robust corrective and/or preventive actions are put in place to address external customer complaints
• Review the Device Risk Management Files to ensure the customer complaint being investigated is appropriately represented
• Collaborate with Device to update the Device Risk Management files, as needed.
• Review and approve reportable external customer complaint investigation reports prior to their submission to health authority
• Assist with maintenance of MDCP data across our company's IT systems, including but not limited to SAP ECC, SAP PLM, and Veeva Quality and Regulatory Vaults
• Coordinates, approves as Quality role all creations and changes to SAP master data field ZZMAT_MDCP_ID
• Submits SAP post-approval updates to GCM TW team to complete the same MDCP identifier updates GCM updates
• Maintains SAP access and role mapping for Device Quality & Regulatory Complaints team
• Supports team as LMS training system steward
• Maintains team SharePoint sites
• Maintains MDCPQ mailbox and associated activities
• Maintains metrics and reporting associated with MDCP deviations, changes, CAPAs and complaints

Education/Experience Minimum Requirement

• 1-3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.
• Required: Bachelor’s degree in Science, Engineering, Health Care, STEM or related technical field

Required Skills

• 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 work independently and have excellent interpersonal relationship skills with flexibility to adapt to a fast-paced environment with changing priorities. Ability to work in a matrix organization and effective written and oral communicator.

Preferred Experience And Skills

• Working knowledge of applicable medical device regulations (21CFR820, EU MDR, ISO 13485:2016), Risk Management Experience (ISO 14971:2012).
• Experience in Complaint Handling investigation process
• Understanding of Combination Product regulations (21 CFR Part 4 including Post Market Safety Reporting requirements).

#EligibleforERP

Required Skills

Adaptability, Complaints Investigation, Creative Thinking, Cross-Functional Teamwork, Detail-Oriented, Problem Solving, Working Independently

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. 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 Affiative 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.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

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

Hybrid

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

11/10/2026

• 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.

Requisition ID: R425437