Specialist, Quality Systems & Compliance

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

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:

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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.

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The primary location for this posting is:

• USA - New Jersey - Rahway
• Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

• $87,300.00 - $137,400.00
• This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

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.

Emp