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Quality Control Supervisor

Date: Nov 20, 2020

Location: Saint Louis, MISSOURI, US

Company: bioMérieux

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. bioMérieux’s global headquarters is located in Marcy L’Étoile, France, and we have more than 11,200 team members in 43 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc., our Americas division, has more than 4,000 team members across 12 sites or subsidiaries. Our Americas headquarters is in Durham, NC, with nearly 1,200 team members. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.

 

 

Position Summary:

Manage the daily operations within the Quality Control functions of Incoming Inspection of components and raw materials ensuring that materials meet specifications in a timely fashion.  Ensure personnel are properly trained; equipment is maintained / calibrated as appropriate, departmental documentation is current and accurate.  Develop, implement and monitor the performance of incoming inspection Quality Control processes, personnel and methods to assure processes continue to conform to regulatory, quality system, internal and external customer requirements.  Provide the QC Instrument Manufacturing team direction, training, leadership and coordination to ensure compliance to company specifications, workmanship standards, and Quality System requirements.  


Main Accountabilities:

  • Manage QC incoming inspection activities directly related to the manufacture of medical device instruments.
  • Manage the daily coordination of the QC team, ensuring personnel are properly trained and work activities are appropriately assigned to support business needs.  Responsible for the teams timely setup and inspection of components and raw materials.
  • Coordinate the training of new and existing QC Technicians, sharing skills and knowledge as a trainer.
  • Provide direction by coordinating the assignments of all receiving inspection resources in accordance with operational priorities, daily instrument meeting “hot parts”, and dock “hot parts”. 
  • Provide support to Instrument Production in reviewing (approving/rejecting) waivers and non-conformities related to inspection of raw materials.  
  • Resolve gray areas of inspection. Carefully scrutinize/interpret the applicable drawings/SOPs and communicate with subject matter experts to ensure compliance is maintained,  parts are transacted accordingly, and any drawing/SOP clarification tasks are created.  Reviews potential NCs/OOTs prior to creation for concurrence. 
  • Maintain expert knowledge of the incoming inspection processes, including use/maintenance of QC software system.
  • Assign and schedule FAI activities.  Provide oversight for the execution of First Article Inspections of components by the QC team.
  • Responsible for ensuring that QC Inspection Methods are current and accurate.  
  • Maintain a thorough understanding of all specifications, requirements, and procedures adequately to provide input regarding the continuous improvement of each.
  • Use a broad business perspective assists in determining priorities, champions continuous improvements, and move the department in directions consistent with business objectives.
  • Supervise people and assign work tasks, providing feedback, guidance and development for employees.  Must be knowledgeable regarding HR requirements & practices.


Studies/Experience, Skills and Qualifications:

  • Requires a Technical degree and 9 years of work experience or 11 years of work experience in a Quality Control setting having competence in the use of Quality Dimensional Tools and Techniques and expert knowledge of quality systems (SAP/LIMS/Trackwise).  Requires previous experience managing direct reports.  
  • Ability to read/interpret complex blueprints, advanced knowledge of Geometric Dimensioning & Tolerancing (GD&T).
  • Ability to use precision mechanical measuring instruments, coordinate measuring machine, optical comparators, microscopes, measure scopes, meters and other various electrical test equipment.
  • Requires strong interpersonal skills to interacts with all levels of the organization.  Also requires a solid analytical approach to decision making and problem solving, and consistent decision making.
  • Requires the ability to advocate quality improvements in a manner that will foster concurrence rather than resistance.
  • Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.). 
  • Must have an expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
  • Proven skills in leading resources from both a technical and personnel perspective.
  • Advanced ability to effectively communicate written and verbally.
  • Ability to be a leader in groups of peers from production and QC. 


Additional Information:

  • Must be able to push a pallet jack that can weigh up to 600 lbs. 
  • May operate within cool temperatures and low humidity.
  • Constant noise is common due to equipment.
  • Occasional environmental odors may be present.
  • Excellent personal hygiene and appropriate gowning required in production and laboratory areas.
     

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. Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux team members who already identify with these values!

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA

 

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