Position Summary:
The Quality & Regulatory Specialist is integral to our team, providing essential quality control, regulatory insights, and comprehensive support across a range of confidential and critical tasks. This role demands a high degree of precision and dedication, ensuring our operations not only meet but exceed industry standards.
Responsibilities:
- Manages customer inquiry and complaint resolution processes.
- Directs the Corrective and Preventive Action (CAPA) program.
- Leads the management of the Nonconformance, Internal Deviations, and equipment calibration and maintenance programs.
- Reviews and approves incoming product acceptance documentation (Verification of Purchased Product) and shipment release.
- Manages and monitors Supplier Assessments and Evaluations and Re-evaluations Program.
- Facilitates the management of Quality Documentation and Records.
- Provides supports for all audits and inspections activities.
- Acts as liaison between our team and suppliers regarding Technical Documentation/data.
Qualifications:
- A Bachelor’s Degree is required, with a strong preference for candidates holding degrees in scientific fields.
- 3-5 years in Quality Assurance and/or Regulatory roles within regulated industries.
- Knowledge and understanding of FDA QSR and/or ISO 13485. MDSAP a plus.
- Advanced skills in MS Office applications, particularly Word and Excel.
- Attention to detail.
- Prior experience in a medical device, pharmaceutical, clinical or healthcare environment is desirable.
- Excellent proficiency in English, with proven ability to proofread and edit technical documents
- Certifications in regulatory affairs or quality management would be a plus.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Experience level:
Schedule:
- Day shift
- Monday to Friday
Ability to Relocate:
- Springfield, NJ 07081: Relocate before starting work (Required)
Work Location: In person