Quality Manager

Reports to President

Company Overview

D. A. Surgical provides reusable and single-use surgical table accessories focused on patient, staff, and equipment safety.

• TrenGuard® is the company’s flagship product. It is a standard of care positioning device for patients being placed in the Trendelenburg position.
• ArmGuard® provides has an application in any surgical procedure utilizing the supine position.
• FaceGuard® acts as both a patient face protection device and a versatile table-mounted instrument tray.
• ShroudGuard® protects surgical table pedestal shrouding from accessory clashing damage.
• D. A. Surgical devices have applications for usage during conventional and robotic-assisted laparoscopy and open surgery for specialties including Urology, GYN, General, and ColoRectal.

Responsibilities

The Quality Manager position oversees and manages the Quality Management System and quality-related matters for D. A. Surgical.

• Manage the Quality Management System (QMS), including personnel training and assuring individual compliance.
• Analyze and evaluate quality systems/procedures to ensure compliance with 21 CFR Part 820 and ISO 13485:2016
• Align individual, departmental, and organizational activities to achieve the established quality objectives.
• Communicate with management, suppliers and customer service on quality-related issues.
• Manage the Internal Auditing system.
• Process non-conforming material and maintain QA Hold
• Function as the in-house expert on the QMS
• Oversee the quality technology tools, EQMS, and SharePoint
• Troubleshoot and problem-solve quality-related challenges.
• Partner with external organizations as appropriate to align the D. A. Surgical quality system with regulations
• Other duties as assigned.

Qualifications, Education and Experience

Necessary and desirable qualifications include, but are not limited to, the following:

• Bachelor’s Degree or equivalent preferred or a minimum of 5 years of related experience as a Quality Manager, Project Manager, PPM, or Production Manager.
• Lead auditor certified (ISO 13485:2016) required. Experience leading and/or supporting FDA inspections, ISO, and Notified Body Audits
• Must have strong attention to detail
• Strong understanding of good manufacturing practices.
• Deep understanding of ISO standards – Class 1 Medical Device experience preferred.
• Excellent communication and interpersonal skills
• Ability to work well under pressure
• Demonstrated ability to work effectively across functional areas with various levels of employees.
• Ability to work independently and as a team-player and work well with others.
• Ability to analyze a situation, problem solve and create solutions.
• Excellent time management and organizational skills.
• Proficient in Microsoft Office Suite and CDRM software. CAD experience a plus.

Working Conditions

Working conditions are normal for an office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, video conferencing, etc. Work may require some weekend and evening work.

Physical Requirements

This position may include physical demands such as the ability to intensely focus and handle stressful situations. You will primarily be working on a computer and sitting in this role.

Reasonable accommodations can be made to employees with qualified disabilities who can perform the essential functions of the job, so long as there is no undue hardship created upon the organization or other employees within the organization.

Job Type: Full-time

Pay: $80,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental Insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: Hybrid remote in Newbury Center, OH 44065