Specialist, Quality Systems & Compliance
About The Position
The Specialist, Quality Systems & Compliance in Device Regulatory & Quality supports the MDCP Complaints team and other DQ&R Systems tasks and priorities. The role works with cross-functional teams and sites to review documentation for compliance with applicable Combination Product or Medical Device regulations and company requirements. It also executes MDCP projects and supports the device data domain. The Specialist reviews reportable external customer complaints and investigation reports, supports complaint investigations and corrective or preventive actions, and reviews device risk management documentation. The role also maintains MDCP data across company IT systems, coordinates specified SAP master data updates, supports access and role mapping, and maintains team training, SharePoint, mailbox, metrics, and reporting activities.
Requirements
- 1–3 years of 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 a related technical field.
- Ability to work effectively in teams and independently within a cross-functional framework.
- Ability to perform detailed technical writing and review.
- Creative thinking, resourcefulness, and networking skills to coordinate projects or solve problems.
- Excellent interpersonal relationship skills and flexibility to adapt to a fast-paced environment with changing priorities.
- Ability to work in a matrix organization.
- Effective written and oral communication skills.
Nice To Haves
- Working knowledge of applicable medical device regulations, including 21 CFR 820, EU MDR, and ISO 13485:2016.
- Risk management experience, including ISO 14971:2012.
- Experience in complaint-handling investigation processes.
- Understanding of Combination Product regulations, including 21 CFR Part 4 and post-market safety reporting requirements.
Responsibilities
- Review reportable external customer complaints upon intake to assess whether they are appropriate for health authority submission.
- Review and approve documentation in the complaint database.
- Collaborate with Site Complaint Investigating Units and Device Technical Operations to ensure device and device components are considered in root cause analyses, including design considerations when manufacturing or packaging root causes are not identified.
- Collaborate with Site Complaint Investigating Units and Device to ensure robust corrective and preventive actions address external customer complaints.
- Review Device Risk Management Files to ensure investigated customer complaints are appropriately represented.
- Collaborate with Device to update Device Risk Management Files as needed.
- Review and approve reportable external customer complaint investigation reports before submission to health authorities.
- Assist with maintaining MDCP data across company IT systems, including SAP ECC, SAP PLM, and Veeva Quality and Regulatory Vaults.
- Coordinate and approve, in the Quality role, creations and changes to the SAP master data field ZZMAT_MDCP_ID.
- Submit SAP post-approval updates to the GCM TW team to complete corresponding MDCP identifier updates.
- Maintain SAP access and role mapping for the Device Quality & Regulatory Complaints team.
- Support the team as an LMS training system steward.
- Maintain team SharePoint sites.
- Maintain the MDCPQ mailbox and associated activities.
- Maintain metrics and reporting associated with MDCP deviations, changes, CAPAs, and complaints.
Benefits
- Medical, dental, and vision healthcare and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
