Quality Assurance Manager - Medical Device at Eurofins

San Jose, California, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Jul, 26

Salary

100000.0

Posted On

24 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, CAPA, Quality Management System, Laboratory Practices, Auditing, Medical Device Regulations, Biopharmaceutical Experience, Project Management, Leadership, Data Review, Chemistry, Communication, Negotiation, Problem Solving, Training

Industry

Medical and Diagnostic Laboratories

Description

Company Description Eurofins 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 Description This 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 System Implements, prepares, and presents training programs as required to satisfy regulatory requirements Applies industry experience to establish and implement best laboratory practices and quality system standards as related to compliance Performs QA review and approvals as required Maintains current records for required certifications and/or accreditations Communicates with client and agency auditors, responds to findings, and effectively addresses concerns or findings Provides information for monthly/quarterly reports to senior site management Identifies, implements, and assures adherence to effective quality control measures Mentors QA staff and provides leadership through demonstration of the vision, values, and strategic goals of the company Leads complex projects through to completion Communicates effectively with client staff members Performs other duties as assigned Qualifications Authorization to work in the United States indefinitely without restriction or sponsorship Bachelor’s or Master’s degree in science field from a four year college/university or equivalent education and job experience At least five years of medical device (preferred) /biopharmaceutical experience with some data review responsibilities and a working knowledge of regulatory requirements Solid understanding of chemistry/lab practices. Knowledge of auditing techniques Self-confidence, leadership, ability to reason, make sound decisions, and delegate Empathy and sensitivity towards others Motivation to excel and inspire excellence in others Ability to manage the work of others and see projects through to completion Strong communication including verbal, writing, and presentation skills Ability to communicate effectively and relate well to people Mental and emotional stability and maturity Ability to handle personal stress and diffuse stress in others Strong organizational skills and ability to handle multiple priorities Sets positive example for others Dedication to quality, ethics, and customer service Pride in appearance, conduct, and company Ability to work effectively under pressure to meet deadlines Good negotiation and reasoning skills Excellent written and verbal communications skills Good judgment and tact recognizing and solving problems Recognized as understanding, interpreting, and following company policy Additional Information Position 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/year Excellent full-time benefits including: Comprehensive medical coverage, dental, and vision options. Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer. Compensation: USD 80000 - USD 100000 - yearly

Responsibilities

The Quality Assurance Manager leads the department to ensure compliance with regulatory standards and company quality goals. Responsibilities include managing QA/QC activities, overseeing audits, implementing CAPA actions, and mentoring staff.