Responsibilities:
- Develop and implement quality management systems and processes to ensure compliance with industry standards and regulations.
- Conduct quality audits to assess the effectiveness of existing quality systems and identify areas for improvement.
- Collaborate with cross-functional teams to establish quality goals and objectives.
- Oversee the quality inspection process to ensure products meet specifications and customer requirements.
- Analyze data and trends to identify root causes of quality issues and implement corrective actions.
- Manage projects related to quality improvement initiatives.
- Stay up-to-date with FDA regulations and industry best practices in quality management.
- Provide training and guidance to employees on quality systems and procedures.

Skills:
- Strong analytical skills to analyze data and identify trends.
- Extensive knowledge of quality management principles, practices, and techniques.
- Experience conducting quality audits and implementing corrective actions.
- Proficiency in using quality inspection tools and equipment.
- Ability to fabricate, interpret, and apply technical specifications and drawings.
- Familiarity with HACCP (Hazard Analysis Critical Control Point) principles.
- Project management skills to effectively plan, execute, and monitor quality improvement projects.
- Knowledge of FDA regulations related to the manufacturing industry.
- Strong attention to detail and commitment to delivering high-quality products.
- Excellent communication skills to effectively collaborate with cross-functional teams.

Note: This job description is intended to provide a general overview of the position. Other duties may be assigned as necessary.

Job Type: Full-time

Salary: $130,000.00 - $140,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• ISO 13485: 5 years (Preferred)
• Quality assurance: 5 years (Preferred)
• Quality control: 5 years (Preferred)

License/Certification:

• Lean Six Sigma Black Belt (Preferred)

Ability to Relocate:

• Cambridge, MA: Relocate before starting work (Required)

Work Location: In person