Quality Manager

POSITION

PURPOSE:

This position will fill a key leadership role in building and directing all company regulatory and quality system activities as it moves forward to develop and market its products. Oversees Quality for two plant locations;
Sanford, ME and Westborough, MA

ESSENTIAL JOB FUNCTIONS-RESPONSIBILTY & AUTHORITY:

1. Develop, implement, and lead an effective, globally complaint quality system to direct the design, the production, and distribution of company products. Including the development and transfer of projects with OEM contractors.

2. Direct regulatory due diligence and routine audits of internal operations and global contract suppliers to assure required regulatory compliance.

3. Direct and lead the regulatory requirements training in a dynamic organizational environment.

4. Act as the key company contact when interfacing with regulatory authorities.

5. Daily analysis of the material to be released.

6. Daily responsibility in walking and auditing the floor.

7. Responsible to check daily and weekly the scrap status, managing a dedicated meeting.

JOB REQUIREMENTS:

1. Ten years of management experience in a regulatory / quality systems leadership role with a product development focused company

2. Proven capability in leading the team

3. Excellent working knowledge of US and EU regulations for medical device products.

4. Direct experience in working with US and EU regulatory authorities for medical devices.

5. Demonstrated leadership and management skills to direct responsibilities in an organization with both internal and outsourced globally directed projects.

6. Demonstrated balance of strategic thinking and execution oriented skills.

7. Excellent written and verbal communications skills

8. Experience with multi-standard management systems, including ISO 13485:2015, ISO 9001:2015, FDA QSR 820.00, ISO 14001:2015.

9. Position may require handling, labeling, moving and monitoring Hazardous and Universal Waste and will require training applicable to waste handling responsibilities.

10.
Preferred - B.S. degree in a biological or natural science (biology, microbiology, biochemistry, chemistry, etc.)

PHYSICAL REQUIREMENTS:

1. Employee will be required to sit / stand for extended periods of time, operate a computer and keyboard.

2. Position will be exposed to office environment with occasional interaction in a production and / or laboratory environment.

Job Type: Full-time

• 401(k)
• 401(k) matching
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Work Location:

In-office/non-remote position

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