JOB SUMMARY: Maintain the quality system and support outgoing product quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices.

ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.

• Assist in the design and development of new products by contributing to risk analysis, verification and validation test plans, etc.
• Apply statistical techniques and risk analysis to internal processes.
• Conduct problem solving with Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8D.
• Approve Engineering Change Orders, review prints and be familiar with Geometric Tolerancing.
• Maintain Quality Records.
• Perform Corrective Actions and Non-conformance assessments.
• Assist in investigating customer complaints.
• Perform internal audits as well as supplier audits.
• Support Incoming Inspection.
• Review Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trends.
• Participate in and lead continual improvement projects
• Support environmental and sterilization monitoring
• Some travel required for supplier support

NON-ESSENTIAL FUNCTIONS:
In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor.

QUALIFICATIONS:

• Bachelor’s Degree in Engineering, Science, or Math or equivalent experience.
• Good written and verbal communication skills.
• 2-5 years of previous engineering experience.
• Proficiency with Microsoft Office tools.
• Proficiency with basic statistics (mean, standard deviation, etc.).
• Experience working in medical device or another regulated industry.
• Ability to apply statistical tools to quality problems.
• Experience with root cause analysis and corrective and preventive action.
• Proficiency at reading engineering drawings and schematics.
• Risk management experience.
• Desirable additional qualifications:Familiarity with ISO 13485, EU MDR, and 21 CFR Part 820.

Experience working in a production environment
Experience with mechanical inspection techniques and/or metrology.
Lean Six Sigma experience.
ASQ Certified Quality Engineer
Experience as an internal, external, or supplier quality auditor.
Gage R&R study development.
Experience managing measurement equipment calibration.
Proficiency with Minitab statistical software.
Knowledge of Geometric Dimensioning and Tolerancing.
Experience with biocompatibility and sterilization testing.
Experience developing process metrics.
Project management experience.

Job Type: Full-time

Pay: Up to $110,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

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

Application Question(s):

• Will you now, or in the future, require sponsorship for employment visa status (e.g., H-1B visa status)?

Education:

• Bachelor's (Preferred)

Experience:

• Medical device: 2 years (Preferred)
• Schematics: 2 years (Preferred)

Work Location: In person

Please Note :
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