Senior Quality Engineer

Who is MMD Medical?

MMD Medical is a cutting-edge medical parts manufacturer that enhances speed and cuts costs by engineering efficient processes.

At MMD our culture & values are our competitive advantage. Engrained in everything we do are our values of Collaboration, Results-Driven, Continuous Improvement, Integrity, and Customer Satisfaction. Sound like you? Apply to join our team today.

What You'll Love about MMD Medical:

• Excellent benefits package including medical, dental, life insurance, short term and long term disability, flex spending, 401k match, and MORE!
• Quarterly bonus for all employees
• Generous PTO offerings & 9 paid holidays annually
• Great opportunities for growth & advancement
• An Employee focused environment that hires and develops talent based on our values
• Clean, Air Conditioned, and friendly work environment
• Casual Dress Code

Essential Duties:

• Team Collaboration and Customer Interaction:
  • Work cooperatively with all employees in a team environment.
  • Serve as the quality representative on cross-functional new product development and production teams.
  • Respond promptly and professionally to internal and external customer requests pertaining to quality.

• Regulatory Compliance and Quality Systems:

  • Initiate and maintain regulatory requirements for FDA, ISO, and other applicable standards.
  • Develop and maintain Validation/Qualification Protocols to meet regulatory and customer requirements.
  • Perform internal audits based on established schedules and regulatory standards.

• Product Quality and Improvement:

  • Develop inspection procedures, standards, and equipment to maintain product quality.
  • Work closely with the metrology team on product inspections, capability studies, and gauge R&R.
  • Review data for accuracy prior to customer submission.

• Root Cause Analysis and CAPA:

  • Utilize robust Root Cause Analysis (RCA) skills to investigate and determine the root cause of product quality issues and defects.
  • Implement effective solutions to resolve quality issues identified through RCA.
  • Assist production and other personnel with the Corrective Action process.

• Continuous Improvement:

  • Identify and implement continuous improvement opportunities to streamline production and quality systems.
  • Establish and execute quality priorities aligned with company goals and customer expectations.

• Team Mentorship:

  • Provide mentorship and guidance to team members to enhance quality skills and capabilities.

Qualifications:

• Bachelor's degree in engineering or equivalent experience.
• Valid identification and the ability to work legally in the United States.
• 3-5 years' experience in quality, preferably in a manufacturing environment.
• Strong knowledge of FDA regulations, ISO standards, (particularly ISO 13485), CFR 820, and AS9100.
• Excellent interpersonal and communication skills.
• Proficiency in Microsoft Office, Minitab, and ERP systems (e.g., Epicore).
• Strong data analysis skills and understanding of statistical process control (SPC)
• Demonstrated ability to lead large, complex programs and mentor team members.
• To be able to perform daily tasks safely; to work independently with limited supervision; To be able to effectively apply problem solving techniques and work with customers, vendors and other departments; to manage multiple priorities.

Physical & Mental Demands:

• Walking and stair climbing is required within the office/shop areas. Sitting, standing, turning the head and torso, reaching, grasping, bending and flexing the arms, legs, wrists, and fingers are physical requirements. Must have correctable eyesight and good depth perception. Must be able to walk, sit and occasionally climb and balance.
• Must be able to prioritize multiple tasks and complete them within a timely manner; Ability to make decisions with limited information.

The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Work Environment:

This is a non-smoking, professional tool shop with normal lighting, and climate control. This position requires the employee to work on a manufacturing floor where they may be subject to airborne contaminants and chemical odors, exposure to heat, noise, dust, dirt, oil and waste

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Protective Clothing Required: When in certain locations of the facility, eye and ear protection are required. Closed-toed/ Slip resistant shoes are also required in certain locations.

We are proud to be an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, veteran, marital, or disability status.

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Velosity is an E-Verify employer.

Velosity maintains ITAR-compliant operations in our facilities. Due to ITAR regulations, this role is only open to U.S. Citizens, lawful permanent residents (green card holders) or foreign nationals granted refugee or asylee status. Individuals with temporary visas (e.g. E, F-1, H-1, H-2, L, B, J, TN or OPT) are not eligible for hire in this role.