Are you a high-potential Quality Engineer or Assistant QA Manager looking to take the next step into a leadership role? Spherion is partnering with a premier medical device component manufacturer in Waco to find a Quality Assurance Manager / Site Lead.
This is a "Management Representative" role where you will own the Quality Management System (QMS). We are looking for a candidate who values precision over speed and is ready to be the face of the facility during critical regulatory audits.
The Challenge
In this environment, "Fast" is secondary to "Right." This role is perfect for a methodical professional who enjoys the discipline of high-level compliance. If you find satisfaction in airtight documentation and process integrity, you will thrive here.
Core Responsibilities
- Site Compliance Lead: Act as the primary Management Representative for ISO 13485 and 21 CFR 820 standards.
- Audit Ownership: Lead internal audit programs and serve as the primary host for external registrar and FDA inspections.
- QMS Management: Oversee CAPA, MRB, and Document Control systems to ensure 100% audit readiness.
- Process Oversight: Supervise a small team of inspectors, fostering a culture of "Quality First" on the production floor.
- Reporting: Provide key quality metrics and data analysis to corporate leadership.
Qualifications
- Education: 4-year Science or Engineering degree (Required).
- Experience: 3+ years of experience in a highly regulated manufacturing environment (Medical Device, Aerospace, or Pharma strongly preferred).
- Technical Knowledge: Proven experience with ISO 13485 or ISO 9001 standards.
- Soft Skills: Exceptional patience, attention to detail, and the ability to remain calm under the pressure of an audit.
Why Apply?
This is a rare opportunity to move into a Managerial/Site Lead capacity without needing 10+ years of prior management experience. It is the perfect role for a Senior QE ready to prove their leadership capabilities in a stable, professional environment.
Pay: $60,000.00 - $80,000.00 per year
Work Location: In person
