The Quality Engineer works with local and international R&D product development teams to ensure compliance to the Quality System for drug injection delivery system product concept through industrialization and commercialization. The position has review and approval authority on project documentation in coordination with internal business partners and external business partners. This includes, but is not limited to: project design specifications, drawings, plans/protocols/reports related to design verification/validation, method validation, risk management activities, change controls and other documentation). The incumbent assures that project output meets combination product regulatory requirements. This position assists in the development and implementation of site/worldwide quality system GMP policies and procedures for management of drug injection system design control processes. Additional responsibilities will ensure departmental compliance in generating and maintaining design control files (DHF’s, DMR’s). The incumbent will conduct audits as needed on files generated as well as represent the company in external audits of CMO’s, CDO’s, and other external business partners. The position supports device design projects at multiple international sites as required. Ability to adapt to product market trends is expected
5 – 10%. Must have ability to travel internationally. Ability to travel long distances, including extensive air travel could be intermittently required.
Essential Duties & Responsibilities
Provide quality compliance support for local and satellite design and development teams as required. Review and approve project documentation in partnership with internal business partners and external business partners (product design specifications, drawings, plans/protocols/reports related to design verification/validation, method validation, change controls, non-conformances and other applicable documentation) to confirm that the output meets combination product regulatory requirements.
Actively participates in the development of the West Chester site Quality Management System (QMS) in support of design control development of drug injection devices
Participate in IQ/OQ/PQ activities including the drafting or review of protocols and validation reports.
Assist in selection and qualification of device CMOs. Negotiate quality agreements with CMO’s as needed. Execution and follow up of CMO audits. Travel as required
Work with project leaders and both internal and external team members to ensure that all development work meets applicable ISO and CFR QMS requirements
Actively participate in the compilation, review and auditing of Design History Files – both internal and external to Teva
Liaise as needed with Teva sites to assure compliance with combination product regulations. Gap analysis activities both internal and external with CMO’s
Participate in Corrective Action / Preventive Action (CAPA) initiatives
Compile training material and conducting training sessions on quality protocols internally/externally
Assist in tabulation and evaluation of data concerning quality and reliability
Examine industry quality compliance strategies and assures that industry best practice is utilized
Bachelor’s Degree in science, engineering, or technical field.
Background in mechanical engineering highly desirable
Experience in the medical device and/or combination products field.
Working experience of medical device GMP Quality Systems and related requirements (FDA 21 CFR820, ISO 13485) is required.
Medical device/combination product industrial and /or design control experience.
Well-developed and proven organizational skills
Working knowledge of device regulations relating to drug injection systems is highly desirable (FDA 21 CFR820, FDA 21 CFR Part 4, ISO 13485 and other ISO standards, EU Medical Device Directive, ASTM, ANSI)
FMEA / risk analysis experience highly desirable.
Injection molding experience highly desirable
Previous experience on multi-site and multi-design device/combination product development teams is highly desirable.
Previous experience with drug injection devices (syringes, auto-injectors) is highly desirable
ISO 11608 series - Needle-based injection systems for medical use is highly desirable
Specialized or Technical Knowledge Licenses, Certifications needed:
21 CFR Part 820 – Quality System Regulation – Medical Devices
21 CFR Part 4 – cGMP Requirements for Combination Products
ISO 13485 – Medical Devices – Quality management systems
ISO 14971 - Medical devices — Application of risk management to medical devices
ASQC Certification(s) highly desirable
Understanding of the pharmaceutical regulations is 21 CFR Part 210/211/600 is highly desirable
Company/Industry Related Knowledge:
Working knowledge of Device regulations (FDA 21 CFR820, ISO 13485 and other ISO standards relating to medical devices)
EU Medical Device Directive knowledge is desirable
ASTM, ANSI standards