Senior Quality Engineer / Drug Delivery Medical Device (JP4331)

Location: Thousand Oaks, Ca
Date Posted: 06-05-2018
Job Posting Title:  Senior Engineer / Drug Delivery Medical Device (JP4331)
Location: Thousand Oaks, Ca
Duration: 24 months with likely conversion to FTE or extension
Business Unit: Device Quality

3Key Consulting is looking for a Senior Engineer for a leading, international pharmaceutical company headquartered in Thousand Oaks, CA

Must have skill sets:
(1) Biomedical engineering, Mechanical engineering background
(2) 2-3 years of experience device design control or combination products, change control and NC/CAPA
(3) Some experience with design risk management
(4) Quality engineer be able to work with minimal oversight, critical thinking.

Red flags:
No resume with drug experience only. It should be drug and device or only device experience.
No resume with over 5-7 years of experience in industry

Day to day responsibilities / first 30 days:
- Work on sustainment and continuous improvement of commercial products as it relates to Pre-filled syringes, autoinjectors and electromechanical devices (medical device perspective).
- Review and approve design control and risk management documentation
- Provide Quality oversight for NC, CAPA, Change control and complain related documentation
- Identify opportunities for continuous improvements for commercial devices

Employee value proposition:
Position has opportunity to develop the individual into a Quality engineering role for Drug and device combination product. This is very hot item/fast growing industry for medical devices. Position has potential to become full time depending on Amgen business growth.

Job Description:
As a member of Amgen's Commercial Quality group for drug delivery systems, this position will provide Quality engineering support for new product development and ensure design control systems are followed in the creation of new drug delivery devices.

Responsibilities include participation in Design development, Design control per FDA CFR 820.30, Corrective and Preventive action projects; responsible for documentation related to investigation of product complaints, trending of quality data, and other assignments as given.

With general guidance, employee will work with process development and operations to ensure robust designs are verified, validated, qualified and launched. In addition to new development the responsibilities will include working on cross functional teams to understand product inquiries, reduce complaint rates and provide support for troubleshooting operational issues and capital projects.

Experience with Quality systems should include: ISO 13485 or FDA CFR 820.30 related compliance regulations and management of engineering development procedures.

Employee will develop, organize, analyze, present and implement results for operational issues or engineering projects of moderate scope and complexity.

Basic Qualifications:
- BA/BS in Science, Engineering, or related field
- 2-3+ years of Quality or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in design verification, design validation, investigations and/or change control

Preferred Qualifications:
- Knowledge of Design Controls
- Experience with product design enhancements/improvements
- Experience in interacting with regulatory agencies
- Good written and verbal communication skills
- Ability to interpret and apply regulatory and quality requirements
- Ability to work independently as well as on teams
- Ability to prioritize and manage multiple tasks
- Ability to work in a challenging and fast-paced work environment

Interview Process: Phone interview then panel F2F for viable candidates.
3KC Talent Acquisition Team
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