Complaint and Document Control Associate

Our Company:

 

At Bioplate, Inc. we understand the challenges that every surgeon and their team face.. Our success is built through precision, high quality service and relentless product innovation. Over the past ten years we have introduced innovative, high quality products into the cranial closure market. The quality of our products derives from the high caliber of our staff, from our first-hand experience in the field of medicine, and from the technical expertise of our partners. Bioplate, Inc. is all about precision, high quality and innovative thinking. All our efforts are concentrated on designing new products, testing new materials and developing new ideas for the market place. Through these efforts, Bioplate, Inc. continually strives to remain competitive and provide you and your team with a "solution for every head."

 

Job Duties

 Assist in management of the document control systemCoordinate customer complaints and failure investigations as well as recommend appropriate corrective action to product regulatory committeesEnsuring the database of documents is accurate, updated, and maintain the document management systemAssist with investigation and routine quality issues identified during document reviewFamiliarity with "change control" procedure in medical device manufacturing is highly desiredProcess change requests for product and quality documents Route and track documents within the approval process for the quality department Perform quality assurance checks before releasing documents Manage, organize, file, and maintain records Proofread and put documents into specified formats Keep track of procedures, forms, reports, and other documents Control revisions of documents including:  identification, assigning numbers, maintaining logs, obtaining approval signatures, releasing, distributing, and recovering inactivated versions Identify and manage customer supplied specifications, drawings, and other documents Maintain training records and transfer to training matrix Compile collected data and format into reports Participates in internal and external audits Assist with preparation of regulatory submission for domestic and international regulatory bodies, including but not limited to regulatory submissions 510(k), technical files for CE marking and CMDR applicationsReview and follow up with appropriate team members to complete paperwork and close out design control files as needed. Review each design control file and obtain approval signatures, dates and ensure that all documentation is completePerforms other related duties and assignments as required

Required Qualifications

 Bachelor’s degree preferredRequires 3+ years experience in quality assurance or related field in the medical device industryExcellent communication skills both written and verbal Strong computer skills with Microsoft Office including Access, VisioExcellent organizational, communication, and interpersonal skillsDetail-orientedDemonstrated knowledge and understanding of FDA, Quality System Regulations (QSR), and ISO 14385 requirements



Skills and Abilities

 Ability to organize and prioritize workflow and to meet established timeframesAbility to maintain updated knowledge of procedures, products and activities of assigned areaAbility to coordinate the work of othersAbility to accurately proofread documents

We offer a competitive compensation package which includes employer paid HMO medical/dental/vision coverage, 401(k), Profit Sharing and tuition reimbursement.