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
Didn't find what you're looking for? Search again!
Loading more jobs...