This position is on site in Beverly, MA.The main roles of a Quality Assurance Associate include, but are not limited to the following:- Auditing device history records and other quality records to assure compliance to in-house specifications, ISO 13485, and other standards/regulations.- Releasing acceptable product for downstream manufacturing use or distribution. Attention to detail is a high priority - the impact of errors is high and can result in rework or rejection of materials, recall of products from the field, citations for regulatory noncompliance, or backorder to customers.- Playing a key role in controlling product from receipt or manufacture through final disposition; including the review of deviations and nonconformities.- Providing input to procedural changes and continuous improvement initiatives, as appropriate. The Specialist helps to identify and implement necessary changes in processes and procedures, in particular, those that impact the Product Release function.- Serving as a resource for Operations on issues pertaining to product documentation, and may spend time directly interacting with all levels of Operations personnel, including management.- May serve as a resource for inter-departmental cross-training on other quality-related tasks.- Participating in measuring and reporting on departmental metrics.- Responsible for ensuring on-going compliance to applicable quality and regulations and standards (e.g., ISO, FDA, etc. as applicable).Position Requirements- BA/BS or equivalent scientific experience required with a minimum of 1 to 2 years of job experience, preferrably within a regulated industry.- Demonstrate multi-tasking and prioritization skills, and in general, have the ability to be flexible, team-focused, organized, and detail-oriented.- Must be comfortable auditing processes, procedures and data, with extended periods of time of computer-based work.- Must be articulate and able to communicate/interact effectively with personnel at all levels of the organization in writing, on the telephone, and in person.- Able to work in an active production environment. During times of heightened regulatory activity, personnel must have the ability to maintain daily activities as well as support company demands. Some extended work hours may be required.- An awareness of basic cGMP, QSRs, ISO standards, and other applicable regulations is desirable.- Demonstrate introductory skill in using Microsoft Office Suite; experience in using an ERP (Enterprise Resource Planning) system and/or EDMS (Electronic Document Management System) is also desirablePersonal Requirements- Excellent communication skills- Detail orientated- Team player- Strong organizational skillsWhat we offerAt the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person’s appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.QIAGEN complies with applicable laws regarding the confidentiality of employee health information and the reasonable accommodation of individuals with disabilities and/or sincerely held religious beliefs. Candidates who require accommodation should contact . This policy is part of QIAGEN’s ongoing efforts to support public health efforts and to ensure the safety and-well-being of its employees, customers, business partners, and community.[
