Quality Assurance Manager

Katmai • Brilliant, OH

29d • Hybrid

About The Position

Responsible for the implementation, monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations.

Requirements

• Minimum of three (3) to five (5) years in the medical device/drug industry, with a minimum of two (2) years of direct experience in QC/QA or equivalent.
• Proven understanding of FDA regulations.
• Proven leadership experience.
• Must have clean driving record.
• Must be able to pass drug test.
• Must obtain and maintain any necessary security access and/or background checks.

Nice To Haves

• Bachelor's Degree preferred.
• Strong Quality Systems background and knowledge of QA/QC principles and compliance.
• Superior communication (verbal, written and interpersonal) skills.
• Good organizational skills.
• Motivated self-starter, ability to multi-task, work independently.
• Aptitude for problem solving, decision making, and an effective cross-functional team participant.
• Computer proficient, Microsoft Excel, Microsoft Word, and PowerPoint.
• Confident team player with strong interpersonal skills.
• Ability to work collaboratively across functions.
• Possess and exhibit professionalism, energy, high integrity, results orientation, and solutions driven.

Responsibilities

• Ensure the Quality System regulations are understood by all applicable company personnel and is functioning and effective at all times.
• Draft, review, maintain, distribute and train personnel on facility documentation and procedures, such as the Quality Manual and Quality System Procedures.
• Ensure compliance with Document Control, Device History Records and Management.
• Maintain Quality System Manual Standard Operating Procedures (QSM SOPs), and Documentation Control.
• Prepare documentation and systems for compliance with the FDA requirements.
• Conduct and participate directly in quality inspections, internal and external audits, and FDA inspections.
• Participate in CAPA systems. Prepare reports and corrective actions.
• Maintain and update the Quality Manual, QA Procedures, and introduce Quality Plan improvements as applicable.
• Assist in analyzing and evaluating information concerning manufacturing problems, customer complaints, non-conformances, quality system, etc.
• Trend customer complaints and/or non-conformances.
• Assist and/or perform training activities in QM system processes and product quality.
• Confer with Operations about quality assurance and regulatory issues of products to ensure compliance with quality system.
• Maintain regular and punctual attendance.
• Perform other duties as assigned.

Benefits

• Medical
• Dental
• Vision
• Life & AD&D Insurance
• Long-Term & Short-Term Disability Insurance
• 401(k) Savings Plan
• Employee Assistance Program (EAP)
• Vacation & Paid Personal Time
• 11 Paid Federal Holidays
• Leave of Absence

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree