Functional Group(s): Document Control, Quality Assurance
Reports to: Director of Quality
Principal Duties and Responsibilities
1. Document Control Duties (Administrative Responsibilities)
a) Maintains master document control system via the Document Change Order (DCO) process. Ensures timely DCO review, approval, incorporation, checking, and release. b) Administers the project document control system to support new product development activities. c) Maintains external document control system to ensure that all external documents referenced in controlled documents are available. d) Prepares and revises controlled documents in accordance with the standard formats. Document types include specifications, procedures, forms, plans, protocols, and reports using word processing and spreadsheet software. e) Maintains various lists, logs and tracking systems related to documents and records utilizing spreadsheet software. f) Releases approved documents including copying, stamping, and distribution. Retrieves superseded and obsolete document revisions to prevent inadvertent use. g) Archives, organizes, and secures various quality records including Design History Files, Device History Records, and Quality System Records to provide for reliable and efficient retrieval.
2. Quality Assurance Duties (Inspection & Test)
a) Inspects products in accordance with written procedures, statistical sampling plans, engineering drawings and specifications as assigned. Documents nonconforming products as appropriate. b) Maintains various quality system logs and records. c) Maintains and operates inspection and test equipment (e.g., optical measurement system, micrometer, caliper, pin gages, microscope, tensile tester, analytical chemistry equipment). d) Provides input regarding inspection methods and quality procedures. e) Ensures traceability of components and products. f) Maintains quality assurance filing systems.
3. Supply Chain
a) Receives incoming materials and supplies, performing inspections as required.
4. General Duties
a) Establishes and maintains Standard Operating Procedures and Forms related to areas of responsibility. b) Works in accordance with quality system procedures. c) Other duties as assigned by Supervisor.
Preferred Skills
1. Good verbal and written communication skills including ability to prepare written procedures and reports.
2. Good organizational and planning skills.
3. Good math skills.
4. Good hand/eye coordination, manual dexterity, color vision, and visual acuity (corrected if necessary).
5. Working knowledge of electronic file management tasks using MS Windows, MS Explorer software.
6. Working knowledge of word processing (MS Word), spreadsheet (MS Excel), and document management (Adobe Acrobat) software.
Preferred Qualifications (Education, Experience, Specialized Training)
1. High School diploma or equivalent certification is required.
2. Minimum three years experience in Quality Assurance/Control or Document Control in a medical device manufacturing environment.
3. Proficient in using software such as MS Word/Excel/PowerPoint and Adobe Acrobat.
4. Experience in reading and interpreting engineering drawing and specifications.
5. Experience with using dimensional/visual inspection equipment including microscopes required.
Job Type: Full-time
Pay: From $80,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
COVID-19 considerations:
BioTrace adheres to all recommended COVID-19 practices: masks required, social distancing, staying home when sick, quarantining after OUS travel, etc.
Education:
- High school or equivalent (Preferred)
Experience:
- Medical device quality control/system: 3 years (Preferred)
Work Location:
- One location
Company’s website:
- www.biotracemedical.com
Work Remotely:
COVID-19 Precaution(s):
- Personal protective equipment provided or required
- Temperature screenings
- Social distancing guidelines in place
- Virtual meetings
- Sanitizing, disinfecting, or cleaning procedures in place
Source: Indeed.com
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