Qa Specialist I Jobs

Summary:
This role holds the responsibility for providing quality support manufacturing, servicing, warehousing and distribution of Zeltiq manufactured products.
Primary Responsibilities (other duties may be assigned):

• Develop training materials for manufacturing site personnel
• Support preparation for regulatory audits
• Develop and maintain effective relationships and integrate activities with other departments and
• Develop quality plans for site projects

suppliers.

• Work with internal customers to ensure that non-conformances are appropriately investigated,

documented, reviewed and approved.

• Assist complaint investigation and preventative risk assessment related to internal production
• Identify and lead projects and initiatives to improve the quality system.
• Assist with calibration and preventative maintenance as needed.
• Help draft and/or update Quality Procedures for Quality Operations functions.
• Provide operation quality support to Product Surveillance/Complaint Handling, Service and repair, as well as product distribution activities.

Qualifications:

• Bachelor's degree in a technical field preferred.
• Proficiency in MS Office suite and database management, and preferably experienced with SAP S/4 HANA and Power BI.
• Minimum of 2 years of medical device quality or equivalent experience in FDA regulated medical device manufacturing environment(s).
• Knowledge of QSR and ISO 13485.

Additional Requirements:

• Ability to read technical literature and documents and extract key concepts.
• Capable of writing reports and conducting data analysis
• Ability to apply mathematical concepts and use MS Excel for calculations and interpretation, such as fractions, percentages, ratios, and proportions.
• Effective communication of project status and issues to team members.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Adherence to regulatory requirements including FDA's Quality System Regulation (QSR) and ISO 13485, Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.

Language and Verbal Skills:

• Excellent communication skills, both written and verbal

Work Environment:

• Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.

Safety:

• Zeltiq prioritizes employee health and safety.
• Location: Dublin, CA-USA
• Function: Global Operations Site
• All employees are expected to contribute to a safe, cooperative, and productive work environment.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• This job is eligible to participate in our short-term incentive programs.
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.