Quality Manager

Quality Manager
Pinebluff, NC
Medical Device
$110,000 - $130,000

Job Responsibilities:

- Champions a quality culture within the organization and communicate objectives across interorganizational levels.
- Responsibility for the ISO-13485 certified quality system to maintain awareness and audit readiness including internal audits, CAPA, and document control.
- Collaborate with department managers and team members to ensure shared vision and goals including hosting regular management reviews with quarterly performance.
- Direct internal investigations regarding customer concerns, determine resolutions and communicate effectively with customers.
- Manage a validation strategy to support IQ/OQ/PQ and actively participate in review and approval of documents.

Supervisory Responsibilities:

- Assists with the hiring, training, and oversight of QA staff.
- Oversees daily workflow and schedules of the department.
- Conducts performance evaluations that are timely and constructive.
- Handles discipline and assists performance improvement initiatives of employees in accordance with company policy.

Qualifications:
- Bachelor’s degree in science (Engineering, Chemistry, Microbiology, or related field)
- Five years of experience in biotech, automotive, medical device, pharma, or related industry.
- Proficient in Microsoft Office Suite, a willingness to learn new technology applications and a basic understanding of statistics and data analytics

Job Type: Full-time

Salary: $110,000.00 - $130,000.00 per year

Benefits:

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

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Quality management: 4 years (Preferred)
• ISO 13485: 4 years (Preferred)
• QA/QC: 3 years (Preferred)
• IQ/OQ/PQ: 4 years (Preferred)

Ability to Relocate:

• Pinebluff, NC: Relocate before starting work (Required)

Work Location: In person