Quality Assurance Manager - Medical Device

Job Description Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.2025, Eurofins generated total revenues of EUR € 7.296 billion, and has been among the best performing stocks in Europe over the past 20 years. Job DescriptionThis position is Responsible for leading Quality Assurance Department in accordance with vision, values, and strategic goals of the company. It will involve overseeing and facilitating efficient quality operations, assuring consistent client service, implementing laboratory practices as applicable to current regulatory standards, working with client and agency audits and correspondence, maintaining certifications, Quality Assurance policy development, and maintenance, following up promptly on any quality and compliance related issues, and implementing respective CAPA actions to assure adherence to the required quality metrics. Other responsibilities are as follows:Manage QA, QC, Regulatory and Compliance activities to help achieve quality/business goals as outlined in the Quality Manual, Policy and SOPs to assure compliance with all applicable Standards and Regulations from all local, state, federal and international sources.Monitor for trends, identify improvements, and assure the effectiveness of the Quality Management SystemImplements, prepares, and presents training programs as required to satisfy regulatory requirementsApplies industry experience to establish and implement best laboratory practices and quality system standards as related to compliancePerforms QA review and approvals as requiredMaintains current records for required certifications and/or accreditationsCommunicates with client and agency auditors, responds to findings, and effectively addresses concerns or findingsProvides information for monthly/quarterly reports to senior site managementIdentifies, implements, and assures adherence to effective quality control measuresMentors QA staff and provides leadership through demonstration of the vision, values, and strategic goals of the companyLeads complex projects through to completionCommunicates effectively with client staff membersPerforms other duties as assignedQualificationsAuthorization to work in the United States indefinitely without restriction or sponsorshipBachelor's or Master's degree in science field from a four year college/university or equivalent education and job experienceAt least five years of medical device (preferred) /biopharmaceutical experience with some data review responsibilities and a working knowledge of regulatory requirementsSolid understanding of chemistry/lab practices.Knowledge of auditing techniquesSelf-confidence, leadership, ability to reason, make sound decisions, and delegateEmpathy and sensitivity towards othersMotivation to excel and inspire excellence in othersAbility to manage the work of others and see projects through to completionStrong communication including verbal, writing, and presentation skillsAbility to communicate effectively and relate well to peopleMental and emotional stability and maturityAbility to handle personal stress and diffuse stress in othersStrong organizational skills and ability to handle multiple prioritiesSets positive example for othersDedication to quality, ethics, and customer servicePride in appearance, conduct, and companyAbility to work effectively under pressure to meet deadlinesGood negotiation and reasoning skillsExcellent written and verbal communications skillsGood judgment and tact recognizing and solving problemsRecognized as understanding, interpreting, and following company policyAdditional InformationPosition is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of San Jose, CA are encouraged to apply.Target compensation: $80,000-$100,000/yearExcellent full-time benefits including:Comprehensive medical coverage, dental, and vision options.Life and disability insurance401(k) with company matchPaid vacation and holidaysEurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.