Document Control Coordinator

Company: B & M Precision Inc
Location: Ruskin
Posted on: May 15, 2022

Job Description:

B & M Precision, a leader in manufacturing stainless steel medical devices, established for over 40 years and is continually growing. We are looking for an experienced candidate with at least 5 years final inspection,document control and engineering experience in a FDA environment to join our winning team. Be a part of a company that puts its employees first and offers growth and opportunity to advance! The Document Control Coordinator is responsible for leading, establishing and maintaining a documentation and engineering change control management
system capable of meeting quality, regulatory and company requirements in a contract medical device-manufacturing environment. This position manages departmental
resources, leads company initiatives, and establishes documentation control and engineering change control policies and procedures. ESSENTIAL DUTIES

• Perform and Document receiving, visual, first piece, in process and final inspections of components, sub-assemblies and finished product for compliance to specifications
• Manage the overall flow and assignment of document control tasks to department personnel
• Manages the company's quality system records and archives
• Collect measurement data for use in First Article Inspection (FAI) reports
• Provide hands-on training to production personnel on use of developed measurement techniques as a result of verification of the first piece and in process inspections
• Performs Internal Quality System Audits
• Acts as liaison between QC and manufacturing engineers to ensure that inspection process capabilities have been verified and appropriately documented
• Develops and execute verification and validation plans associated with product/process and equipment according to FDA QSRs and ISO 13485 Job Experience · 3+ years of document control experience in a FDA regulated environment , including the practical application of FDA Quality System Regulation and ISO 13485 or equivalent · Minimum of 5 years' experience performing in-process and final inspection preferably in a machining , medical device, automotive or aerospace business · Minimum of one year experience using measuring instruments i.e. calipers, comparator, height gauges, dial indicators, micrometers etc. · Strong experience with MS office products, Adobe Visio, Power Point, advanced Word and Excel techniques · Independent self-starter who is capable of planning schedules, control plans and leading projects as assigned, who is able to incorporate FDA, ASTM and ISO standards through the product life cycle, designing and developing the required inspection and process control methodologies · Strong technical writing skills and ability to create technical protocols and reports as well as manufacturing/inspection work instruction and procedures · Ability to internally and externally discuss and clearly define key technical and process development issues and independently develop course of action/plans WORK ENVIRONMENT · The work environment consist of both typical office as well as time on the manufacturing floor as required for training, instruction, investigations, etc. WE OFFER
  • Excellent medical, dental and vision benefits after 60 days; 100% paid for employees and 50% for dependents.
  • Paid vacation, PTO and 8 paid holidays
  • Annual bonus
  • Profit sharing and matching 401K. EOE/M/F/D/V DRUG FREE WORKPLACE We consider applicants for all positions without regard of race, color, religion, sex, national origin, age, marital or veteran status; in the presence of or a non-job related medical condition or handicap; or any other legally protected status.
    
    
    
    PI174921911

Keywords: B & M Precision Inc, Palmetto , Document Control Coordinator, Other , Ruskin, Florida