Quality Engineer – CAPA
Tarrytown, NY – 10591
6+ months contract to start with
Position Overview
This position for a Quality Engineer with strong corrective and preventive action (CAPA) process and software lifecycle development experience with medical device manufacturing. This role is expected to provide leadership for gathering, interpretation and documentation of user requirements as well as provide technical support the quality assurance, process control, and engineering functions with an emphasis on CAPA or is a key contributor to cross functional process improvement and problem solving teams.
Key responsibilities include:
- Ensures compliance to regulatory requirements per CFR §820, ISO 13485, CDMR and other applicable regulations, company procedures for CAPA systems.
- Supports Quality management, which includes ensuring that CAPAs are issued as required, properly investigated, documented, and completed on time.
- Collaborates with site CAPA representatives as well as the Information Technology department to ensure clarity and verifiable user requirements are gathered, documented and translatable to validation efforts of improvement of the electronic CAPA processing.
- Communicates obstacles, provides solutions and leads implementation of new opportunities for improvements to work processes, production, QA review and other areas as identified.
Responsibilities
- Gathers, documents and collaborates Business Requirements for each field of the electronic CAPA processing.
- Reviews current automated reporting and recommends improvement to meet business needs.
- Investigates product / component / production / development issues by conducting failure investigations and trending of causes.
- Manages quality metrics, leads corrective action review board, and develops meeting outcomes to ensure continual improvement of the CAPA process.
Required Knowledge/Skills, Education, and Experience
- BS Engineering, Science or related field is required.
- 5+ year medical device or pharmaceutical industry experience.
- Must have experience with 21 CFR 820 and demonstrated proficiency in statistical analysis.
- Must be proficient with MS software programs, especially Excel.
- Software development lifecycle experience a plus.
- Ability to analyze and solve complex problems as well as the ability to communicate effectively across departments is crucial in this role.
- Must demonstrate effective influencing and change management skills and demonstrated achievements in process improvements.
- This position may travel up towards 20% on an annual basis.
Preferred Knowledge/Skills, Education, and Experience
- CQE or CQA is desirable. Software development lifecycle experience / software validation efforts.
- Previous experience supervising technicians and conducting and participating in FDA / customer / corporate audits is preferred.
- Ability to use MS Office products along with statistical software proficiency is preferred.
Thanks & Regards,
Imran (Emu) Shikalgar
APN Software Services, Inc
39899 Balentine Drive, Suite 385, Newark, CA 94560
510-402-4704 (Voice & Text)
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com
linkedin.com/in/imranshikalgar