We are a fully-integrated, global contract manufacturer providing full-service medical device development and manufacturing for spine, reconstruction, sports medicine & trauma, and extremities markets.Our disruptive renewed strategy allows us to provide true "Concept to Launch" support to OEM customers.
We are able to assist our customers during all stages of their manufacturing journey, from device conception and manufacturing through to finishing and polishing, and eventual packaging.Whatever you need – a single development or manufacturing step or a fully-integrated manufacturing service – we can help you realize your vision, simplify your supply chain, and shorten your overall lead time.As the medical division of Lincotek Group, we have access to a lifetime's experience of coating technologies and innovation, enabling us to support hundreds of OEMs globally in the development of dedicated processes to suit their needs.With bases established in Europe, North America, and Asia, we support our customers wherever they may be located and be responsive to their demands.For our site in Cadriano di Granarolo (BO), we're searching for a qualified and resourceful Quality Documentation Specialist :ABOUT THE JOBUnder the direction of the Quality Manager, the Quality Documentation Specialist is responsible for ensuring that products are manufactured and released in accordance with regulatory requirements and the principles and guidelines of Lincotek Quality Management System.This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring schedules are maintained and medical devices are compliant.MAIN RESPONSIBILITIES:Perform in process and final release of medical device products for E.U.
and international markets including manufacturing,Perform raw material inspection,Perform packaging and labeling batch records inspection to ensure complianceGeneration of associated product release certificates, archiving of electronic and hard copy batch documentationExecute batch record review and review of supporting systemsEnsure all appropriate batch related documents are available, and all documentation issues including queries, deviations, change controls, out of specification and non-conformities are closed to enable release of products in a timely manner.Effectively resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release.Communicates with cross functional team to align on product release timelines and resolve batch record issues.Approve product certification documentsPerform batch record searches in support of complaint investigations and during audit processAssess applicability of current standard operating procedures, device master records and product specificationsCreation of all relevant Work Instructions and ProceduresSupervise the constant monitoring of controlled areas (e.G.
clean rooms, packaging area) in order to maintain a safe and clean working environment by complying with all safety procedures and regulatory requirements.EDUCATION AND/OR EXPERIENCE:High school diploma or Bachelor's degree in Engineering or Science or related scientific discipline1 year of experience in biomedical or pharmaceutical companies is preferredTechnical system skills (e.G.
MS office applications, databases)Experience with SAP or similar systems preferredKnowledge of good documentation practices is preferredSKILLS:Ability to define problems, collect data, establish facts, and draw valid conclusionsManage multiple deadlinesWork proactively on a daily basis to ensure schedules are maintained and material is readily availableExcellent communication skills, including well developedAbility to positively interact with all levels of internal collaborators as well as external suppliers and laboratoriesEnglish: Proficient userWORK ENVIRONMENT:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.POSITION TYPE/EXPECTED HOURS OF WORK:This is a full-time positionLincotek Surface Solutions provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.#J-18808-Ljbffr
