Job description

Quality Engineer

Position Summary

ARCH Medical and Aerospace, a leader in critical component manufacturing for the Medical and Aerospace industries, is searching for a Quality Manager for our Woburn, Massachusetts facility. This position reports to the Quality Manager and will be responsible for ensuring the quality and accuracy of our products in accordance with ISO 9001, ISO 13485, and AS9100 Quality System Standards.

Responsibilities

• Ensure that quality management system (QMS) requirements are adhered to in accordance with ISO 9001/AS9100 and ISO 13485.
• Promote awareness in all departments of regulatory and customer requirements.
• Become a consistent quality presence in the manufacturing process.
• Coordinate and conduct Material Review Board (MRB) activities.
• Perform capability studies to meet customer requirements.
• Prepare and conduct IQ/OQ of new and revised equipment as required.
• Conduct investigations and root cause analysis for the Corrective and Preventive Action (CAPA) system (Internal and Customer)
• Collect and help analyze quality metrics for both customer and Sr. Management needs.
• Assist with training programs to promote awareness and technical requirements for all employees.
• Maintain the calibration system.
• Must be able to handle multiple tasks and work in a fast-paced environment.
• Maintain a safe, clean and organized workspace.
• Miscellaneous quality tasks as required.

Skills, Education, and Experience

• Must have experience with the ISO 9001 Quality Management System standard at a minimum.
• Must have a thorough understanding of Geometric Dimensioning and Tolerancing.
• Must be able to read and interpret mechanical drawings, specifications and inspection instructions and determine product conformance based on such documents.
• Must be able to interact and communicate with coworkers at all levels of the organization with respect and dignity.
• Experience managing a calibration system and performing equipment calibration is a plus.

Job Type: Full-time

Pay: $75,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay
• Signing bonus

Ability to commute/relocate:

• Woburn, MA 01801: Reliably commute or planning to relocate before starting work (Required)

Experience:

• ISO 9001: 1 year (Preferred)
• Quality Assurance Managers: 1 year (Preferred)

Work Location: One location

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