Quality Manager - Medical Device or Pharma Required

Quality Manager
Colonial Heights, Virginia area

Lead a tenured team and drive cultural transformation in a stable, growing plant that offers excellent profit sharing and a beach-access lifestyle!

Lead Real Change: Partner with an energetic Plant Manager to coach a tenured team and drive a high-energy culture shift.

Stability & Growth: Join a diverse plant with 20-year average employee tenure and the open capacity for new business.

Elite Benefits: Competitive salary plus 401k, profit sharing, bonus potential, and free product giveaways.

Beachside Balance: Maintain a true 45–50 hour work week with flexible scheduling, all just an hour away from the coast.

Collaborative Autonomy: Enjoy your own private office while working within a tight-knit, supportive management group.

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Successful, profitable manufacturer is seeking a Quality Manager to oversee the quality systems and plant quality at a growing site. The Quality Manager will report to the Corporate Director of Quality and work closely with the Plant Manager on quality initiatives and will be responsible for the following tasks:

• Monitor and improve the quality management system
• Oversee and ensure regulatory and legal compliance, including leading and guiding all direct reports to ensure compliance
• Manage and lead root cause analysis and ensure countermeasures are completed
• Responsible for validation of new and existing products
• Communicate plant quality KPIs, goals and initiatives to plant management and corporate representatives
• Prepare for and execute internal and external quality audits
• Drive and achieve quality continuous improvement initiatives, including cost savings goals for the plant
• Interact with plant and corporate teams on quality projects
• Develop and maintain key quality performance indicators
• Lead and participate in cross-functional teams related to plant quality
• Partner with R&D for on-site trial activities
• Execute and improve quality training, including quality orientation training
• Complete non-routine quality projects and higher level crisis management
• Assist with vendor qualification
• Other tasks as assigned by management

Candidates must be able to communicate directly and effectively at all levels, be self-motivated, take initiative on projects, be organized, have excellent attention to detail, and enjoy leading and developing their team. This position will spend up to 30% of the time on the manufacturing floor. Medical benefits are available day one of employment. Other benefits include paid holidays, personal days, vacation, 401K, profit sharing, stock purchase plan and bonus potential.

REQUIREMENTS for the Quality Manager:
1. Minimum of a Bachelor’s degree, ideally in a science or technical field
2. At least five years in a similar manufacturing quality leadership position

3. Experience supervising others
4. Experience overseeing quality in medical device or pharmaceutical manufacturing

5. Experience working in GMP or FDA regulated environments

6. Working knowledge of micro-organisms

7. Strong background with root cause analysis and CAPA (corrective and preventative action)
8. Strong quality auditing background

9. Experience with statistical analysis

10. Experience working in established QMS (quality management system) environments, example: ISO 13485

11. Microsoft Word, Excel, PowerPoint and Outlook

Skills preferred but NOT required:
1. Quality certifications
2. Lean and/or Six Sigma
3. ERP experience

4. Power BI

5. Validation experience

Why work for this organization:
Strong tenure in the plant, averaging 20 years amongst all team members
EXCELLENT benefits, including 401K, profit sharing and bonus potential
Excellent work/life balance, averaging 45-50 hours per week with flexibility for appointments/activities

Excellent location; only an hour to the beach

You will have your own office and oversee a tenured team

Work with a solid and collaborative management team, working hard to improve the culture daily

FREE product giveaways; save money on items that you use regularly

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