The Group Lead is primarily responsible for oversight of the Quality Engineering team related to CAPA, Deviations, Complaints, Validations and Supplier Management. Provides support for manufacturing issues; leads or participates site continuous improvement initiatives, CAPA teams and nonconformance investigation teams; performs documentation review.
Manage workflow of Quality Engineering team to ensure department goals are met
Provide day to day supervision of Quality Engineering team, including employee activities such as PMP, Hiring, etc.
Provide leadership and guidance to all levels on quality tools and techniques for quality assurance, compliance and continuous improvement.
Perform and/or support quality investigation activities, including but not limited to Deviation (Waiver, nonconformity, NCMR) Investigation Reports, CAPA and Complaints
Oversee TrackWise record completion, tracking and trending, and adherence to SOP requirements
Write, review, and approve Standard Operating Procedures to ensure they comply with the Quality System and current Good Manufacturing Practices
Initiate and/or oversee changed control activities as needed
Interface between R&D and Industrialization and facilitate Manufacturing Transfers
Perform any additional job related duties as requested
Skills and Qualifications:
BA/BS degree, preferably in a science related field.
Minimum 5 years of experience working in in a regulated environment with knowledge of Good Manufacturing Practices
Minimum of three (3) years of experience independently managing mid to large size projects involving project planning, team leadership and collaboration with multiple departments/functions.
3-5 years experience writing and/or approving investigations (i.e. Nonconformance and CAPA) and mentoring and/or supervising junior associates.
Competence in the selection and use of Quality Engineering Tools and Techniques
Computer skills required, including Microsoft Word, Excel, PowerPoint and Outlook
Excellent interpersonal skills and ability to work with all levels of an organization
Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands
Must be able to work effectively in a team based environment.
Strong technical writing skills
bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally. Its corporate headquarters are located in Marcy l’Etoile, near Lyon, in France.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture.
We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.
We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.
Our Group offers numerous possibilities: so come and join the 10,000 bioMérieux employees who have already identified with these values!