Employment Type: Full-time

Available Positions: 1

Location: On-Site

Application Deadline: June 21st, 2024

Summary

The Quality Assurance Manager will be responsible for Overseeing the Quality Assurance functions. Provides support and makes recommendations to the CEO and senior staff for strategic planning purposes.

Key Activities

• Primary interface with FDA, MDSAP, and ISO auditor(s).
• Interface with engineering in the risk management process.
• Works with state, national, and international stakeholders to improve the quality and safety of products.
• Develop inspection plans/criteria, along with Engineering staff, per prevailing standards.
• Performs inspection as needed.
• Develops and implements methods to inspect and evaluate the reliability of manufacturing process, products, and production equipment(s).
• Defines and maintains process control and equipment calibration.
• Makes sure processes (including outsourcing) and production adhere to quality standards.
• Organizes data collection and information analysis; creates reports.
• Responsible for overseeing/maintenance of the internal audit program.
• Performs external audits for new/current suppliers.
• Does analysis of field failures and customer complaints.
• Maintains Quality Management System.
• Recommends effective corrective and preventative actions.
• Oversees material traceability and lot control.
• Develops an integrated, system-wide plan for Quality and performance improvement.
• Provides evidence-based recommendations for improving business and manufacturing processes.
• Works according to the deadlines for maintaining QMS.

Preferred Skills

• Knowledge of relevant regulatory requirements is preferred.
• MDSAP knowledge a plus
• 93/42/Medical Device Regulations and MDR knowledge a plus
• Experience with FDA Submittals preferred

Educations & Experience

• Bachelor’s degree in engineering, Business, or the Sciences or (5) years of progressive experience in a production environment (medical device/equipment preferred).
• Prior experience in ISO-certified companies; familiarity with ISO: 13485, 21 CFR Part 820.
• Experience with Notified Body Requirements

Are you looking for your next opportunity? We can help.

Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50 years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.

TQR is an equal opportunity employer that encourages diversity. We will consider all applications.

Accommodation for applicants with disabilities is available upon request.

Are you looking to hire? Get started here:

https://www.topqualityrecruitment.com/fill-a-position/

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We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attach your resume to your application.

Job ID: 7277