Manager, Quality Assurance

POSITION: Quality Manager

REPORTS TO: General 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. B.S. or M.S. degree in a biological or natural science (biology, microbiology, biochemistry, chemistry, etc.) preferred.

3. Proven capability in leading the team

4. Excellent working knowledge of US and EU regulations.

5. Direct experience in working with US and EU regulatory authorities

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

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

8. Excellent written and verbal communications skills

9. Experience with FDA-QSR (CFR 820), MDD/IVDD (ISO 9001 / 13485) regulatory requirements for registration and quality systems

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

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

Benefits:

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

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Application Question(s):

• If extended an offer for this position, what would be your availability to start?
• What are your salary expectations for this position?

Ability to Relocate:

• Sanford, ME 04073: Relocate before starting work (Required)

Work Location: In person