Quality Manager

Job Description:

Manage various QMS operations to ensure compliance with written procedures and established processes. Manage inspection activities for components, in-process, and finished products. Oversee calibration and preventative maintenance activities. Work with engineering to resolve manufacturing process quality problems including evaluation of components, suppliers, and manufacturing process. Conduct complaint and CAPA investigations. Interface with regulatory authorities including FDA and notified bodies to maintain compliance with all required regulations.

Job Requirements:

The preferred candidate should meet the following requirements:

• Two or four year technical degree in Mechanical or Industrial Engineering or similar field.
• Experience in process validation, statistical sampling techniques, root cause analysis and related processes.
• Familiarity with FDA Quality System Regulation (GMP), ISO 13485, and related quality standards.
• Previous medical device QMS experience, preferably with sterile devices.
• Excellent verbal and written communication skills in English.
• Regular and predictable attendance.
• While performing the duties of this job, the employee is regularly required to sit, stand, walk, and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and ability to adjust focus. The employee must occasionally lift and/or move up to 50 pounds.

Salary Based on Qualifications and Experience

Apply with resume through posting, email to MedOne@MedOne.com, or complete our online application at MedOne.com. Please do not call. We will contact potential candidates.

Job Type: Full-time, on-site

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance
• Paid Holidays and PTO

Schedule:

•  Monday – Friday, 8 Hour Shift