Job DescriptionPosition Description Quality Control Inspector
Position Title: Quality Control Inspector / Temp to Hire
Department: Quality Assurance
Reports to: Manager, Quality Operations
Date written/revised: April 1, 2024

The Quality Control Inspector reports to Manager Quality Operations and is responsible for inspection of raw materials, sub-assemblies, and finished goods per specifications.
Primary Duties:
•Perform a variety of mechanical inspection, tooling inspection and qualifications. This includes precision dimensional inspection and testing using calibration gauges, measuring instruments and custom inspection and testing tools and fixtures.

• Inspect received and in-house manufactured assemblies, subassemblies, and components to determine if required drawing characteristics and specifications are met.

o Evaluate the acceptability of parts against engineering documentation including but not limited to drawings, specifications, BOMs and inspection checklists.
o Determine the acceptability of product after inspection.

• Maintaining Calibration cycles for production and inspection equipment.
• Coordinate Quality Control input to purchase order submittals and document product acceptance.
• Support non-conforming parts management.

o Document all nonconforming conditions.
o Ensure all defects are clearly identified and documented to allow subsequent processing of the disposition/MRB.
o Ensure effective reporting and communication of nonconforming/MRB issues.

• All other duties as assigned; examples include but not limited to:

o Maintain organization and cleanliness of department using 5S.
o Maintain organization, storage, and calibration compliance of tools.
o Prepare detailed inspection reports and defect summaries as needed.

Critical Knowledge, Skill, and Abilities:

• Quality systems experience performing inspector functions compliant with 21 CFR 820.
• Mechanical inspection experience and previous work with medical devices desired.
• Experience with measuring instruments (Micro-Hite, microscope, optical comparator, micrometer, caliper, etc.).
• Experience with a Keyence Instant Measurement system a plus.
• Experience with calibration equipment and calibration systems.

• Formal training with measuring instruments.
• Experience with Geometric Dimensioning and Tolerancing (GD&T) is desired but not required.
• Ability to handle multiple tasks while maintaining attention to detail and accuracy, working under tight time deadlines.
• Basic computer skills, including data entry.
• Working knowledge of MS Outlook, Word, and Excel.
• Written and verbal communication in English.

Experience/Education:

• Associate Degree or 5 years medical industry experience.
• Knowledge of GMP, FDA QSR, MDD, TQM and ISO 9001 regulations.
• 8 years Incoming, In-Process and finished product Inspection experience.
• 4 years. GD&T experience.
• ASQ Certified Quality Inspector or Quality Technician, preferred. On the Job Training:
• Quality Manual
• SOP’s related to Purchasing; Inspection; Document Change Control; Traceability; Calibration; Equipment Maintenance; Process Control and Corrective and Preventive Actions Physical Demands:

• Duties of this position are generally performed in good working conditions. There may be occasional exposure to elements such as noise, dust, chemicals, operating machinery, etc.
• Duties may require extended periods of sitting and sustained visual concentration on inspection equipment, a computer monitor, or on numbers and other detailed data.
• Duties may require lifting up to 50lbs, squatting, bending, 20/20 vision with corrective lens.
• Potential exposure to blood borne pathogens.

Job Type: Full-time

Pay: $22.00 - $32.00 per hour

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Application Question(s):

• What Industry have you worked in?

Education:

• Bachelor's (Preferred)

Experience:

• Quality Control: 4 years (Preferred)
• Mechanical Inspection: 4 years (Preferred)
• CMM: 1 year (Preferred)
• Medical Device: 2 years (Preferred)

Ability to Commute:

• Woburn, MA 01801 (Required)

Work Location: In person