Quality Engineer II

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

POSITION SUMMARY: Under minimal supervision, this role is responsible for managing complex product-related customer complaints and manufacturing investigations for both Company and Partner products. This includes execution of quality investigations related to pre-market and post-market manufacturing issues, as well as tracking, trending, and reporting of complaint and deviation data. Provides Quality Assurance support across Manufacturing, Packaging, Supply Chain, and Quality Control. Responsible for the review and approval of investigation reports, change controls, SOPs, validation protocols/reports, maintenance work orders, and other cGMP documentation. Leads cross-functional teams to identify trends, determine root cause, and drive process improvements and failure reduction activities. This role requires strong independent problem-solving, data analysis, and the ability to collaborate with all levels of the organization.

 

ESSENTIAL RESPONSIBILITIES:

• Lead and manage investigations for pre-market and post-market manufacturing issues
• Facilitate communication with internal teams and external partners throughout investigation lifecycle
• Perform root cause analysis and identify corrective and preventive actions (CAPAs)
• Analyze and trend customer complaints and manufacturing deviations
• Generate monthly, quarterly, and annual reports by compiling and analyzing data from multiple sources
• Manage complex deviation reports and review/approve non-complex deviations
• Review and approve customer complaint investigations
• Support Manufacturing, Packaging, and Quality Control investigations
• Review and approve change controls, SOPs, validation protocols/reports, and maintenance documentation
• Act as backup for management as needed
• Ensure compliance with company policies, cGMPs, SOPs, and safety standards
• Perform additional duties as assigned

Your Skills and Experience

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. 

 

Education/Certification/Experience:
•    Bachelor’s degree, preferably coursework in scientific or engineering discipline, or equivalent education/ experience.
•    A minimum of 3 years in Quality function, preferably in pharmaceutical, medical device or other regulated industry.

 

Skills/Knowledge/Abilities:
•    Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Trackwise Harmony.
•    Must be experienced at creating performance metrics, having performed the corresponding analysis and reports.
•    Detail oriented, team player with strong interpersonal skills.
•    Demonstrated working knowledge of cGMP and applicable regulatory requirements.
•    Project management or advanced presentation skills desired.
•    ASQ CQE/CQA certification is desired.

Problem Solving:
•    Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
•    Exercises judgment within generally defined practices and policies and selects methods and techniques for obtaining solutions.
•    Normally receives little instruction on routine work and general instruction on new assignments.
•    May be asked to recommend methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
•    N/A

 
PHYSICAL REQUIREMENTS:
Frequent:
•    Sitting for extended periods of time at work station or mobile equipment.
•    Using fingers to perform activities such as picking, pinching or typing.

Occasional:
•    Standing for extended periods of time at work station or equipment. 
•    Walking to move short distances quickly and frequently.
•    Repetitive motions (frequent motions of the wrists, hands and/or fingers).
•    Lifting – raising from lower to upper and/or moving objects horizontally up to 25 lbs.

Visual Acuity:
•    Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/