Job description

Overview

This role will involve day-to-day personnel management to ensure production goals are met. This position will be cross-functional, working closely with other employees to accomplish goals.

Responsibilities

• Understands and adheres to requirements related to Cleanroom standards, and cleanroom mfg process documents.
• Attention to detail related to written specifications and manufacturing instructions to assemble a variety of medical devices.
• Evaluate product assembly to company quality standards.
• Work closely with other employees and supporting departments to address nonconformities relate to documentation within the Manufacturing Instructions of the product.
• Perform cGDP (Current Good Documentation Practice) review of completed Manufacturing Instructions.
• Release Production Manufacturing Instructions to the production floor in the Inventory Management database.
• Perform receipt transactions of completed Manufacturing Instructions.
• Perform closure of lots in the Inventory Management database.
• Perform closure of Time and Labor closure of completed lots.
• Responsible for resolving GDP issues with Document Control and the Quality Departments when required.
• Responsible for training Direct Labor on adherence to cGDP and GMPs (Good Manufacturing Processes).

Qualifications

• High school diploma or equivalent required.
• Ability to read and interpret standard operating procedures and manufacturing instructions.
• Ability to document assembly processes and procedures.
• Prior Medical device assembly experience or working with small parts is a plus
• Candidate should have good eyesight, hand dexterity (hand coordination) and attention to detail.
• Able to sit/gown for extended periods during the shift.
• Able to work in an environment with low and occasionally increase background noise.
• Experience with a quality background is required.
• Experience with Med Device inventory management and transactions is a plus.
• Prior experience using software to process transactions required.
• Experience processing transactions through Great plains preferred.

Job Types: Full-time, Contract

Pay: $27.00 - $30.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift
• Day shift
• No weekends

Ability to commute/relocate:

• Burlington, MA 01803: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing Documentation: 1 year (Required)
• GMP/GLP: 1 year (Required)

Shift availability:

• Day Shift (Required)

Work Location: One location

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