QA Specialist II

　　Quality Assurance

　　Austin , TX, US

　　Pay Rate Low: 18.17 | Pay Rate High: 19.40

　　Added - 27/12/2023Apply for Job

　　A leader in global healthcare, with a mission to help people live life more fully at each stage! Our life-changing technologies span the spectrum of healthcare, ranging from medical devices to branded generic medications, and are utilized in 160 countries. If you are interested in joining a leader in the industry, apply today!

　　QA Specialist

　　Wed-Sat 8am to 6pm (10 hour days)

　　Training 6-8 weeks 9am-5pm

　　Assures the quality of manufactured products and processes per standard operating processes and good manufacturing practices.

　　Will support 3rd party for medical devices, device history records and primarily handling batch records.

　　Must have a minimum of 3 years of experience in a medical device or pharma regulated environment, preferably in manufacturing.

　　HEAVY documentation role doing batch review, doc approvals, following protocols and validation

　　Documentation, Validation, Design Control, lab notebook (design, manufacturing or release)

　　Must have strong attention to detail.

　　Must know and be able to follow procedures, review document requirements and determine if acceptable for procedure and if not escalate

　　Internship, co-ops and schooling will not be considered.

　　BS degree Prefer STEM or 3-7 years equivalent experience

　　Masters degree OK but will not replace years of experience

　　Able to follow procedures

　　Strong attention to detail

　　Strong understanding of med device quality docs

　　This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

　　#LI-DNP

　　We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.