Quality Manager

 B & M Precision is looking for a Quality Assurance Manager with experience in the medical device industry.  The QA Manager is responsible for managing the quality assurance staff for quality assurances of raw materials, finished products, and manufacturing processes.   Including quality system maintenance, audits, Document Control & DHR maintenance, and design control quality attributes.

MAIN JOB RESPONSIBILITIES   

Manages Quality Assurance Lab for inspection of raw materials, sub-assemblies, components    

• In-process audits of finished products, calibration control, and control and disposition of non-conformances, identify and prescribe corrective actions, and approve all material and product releases   
• Manages, maintains, develops and controls the Document Control Office and staff in record changes, updates, and archive of quality records, drawings, specifications, Engineering Change Notices, Label Design, Standard Operating Procedures, Procedure Change Notices, and Device History Records   
• Participates as primary QA representative to MRB / Design Control processes and assists in development of quality manufacturing
   documentation and attribute test methods  
• Leads and supports projects that improve processes and systems for improving product quality, reducing costs and paperwork, and improve efficiencies  
• Generates and identifies root cause, and approve NCR’s and ECN’s for quality assurances or corrective action, and develop product and quality measures and reports for annual management review   
• Reviews and approves complaints and complaint closure letters  
• Communicates daily with Team members, recommends improvements where necessary including design, documentation, and
   inspection methods or related criteria  
• Responsible for participating in FDA and ISO audits, as well as other 3rd party inquiries as required   

 JOB EXPERIENCE   

• Minimum of five years’ experience in a manufacturing environment, preferably medical devices
• Quality inspection techniques and statistical analysis data 

EDUCATION   

Bachelor’s Degree  

SKILLS    

• Excellent oral and written communication skills.  
• Proficiency in the use of PC and programs, particularly Excel, Word, PowerPoint and IQMS.  
• Cross-functionally and an effective team player.  
• Excellent presentation skills.  
• Excellent problem solving, analytical, written communication skills are required.  
• Experience in managing subordinates and strong interpersonal skills are required.  
• Must be able to work in a team environment and exert influence without alienating others.   

WHY WORK FOR US  

• Excellent medical, dental and vision benefits after 60 days; 100% paid for employees and 75% for dependents  
• Paid vacation, paid holidays, PTO, annual bonus, profit sharing and a matching 401k