Serve as an Essential Member and Subject Matter Expert on a Skilled Quality Assurance Team

If you combine strong quality systems or regulatory experience in a medical device manufacturing environment with proven CAPA management skills, knowledge of ISO 13485 requirements and experience performing audits, the role of Quality Systems Engineer with Aspen Medical Products offers you some compelling opportunities. You will:

• Take ownership of a new, critical Quality role added to support our ongoing growth and integral to maintaining and advancing Aspen's strong reputation for quality.
• Join an outstanding Quality Assurance team including inspectors, technicians, document control and others. You'll be able to share your knowledge and add to your skills through mentorship and collaboration.  Quick question for you - click here
• Enjoy the autonomy to own your responsibilities and opportunities to add value as you proactively partner with cross-functional stakeholders, hear multiple perspectives and assist in making changes and improvements.
• Come on board during an exciting time; we are actively expanding our product line in the markets we serve. You'll learn right along with the team.
• Become part of a great family-oriented culture in a "Best Places to Work" environment, with leaders who truly care about employees and place an emphasis on quality of life, fun events and more.  

At Aspen Medical Products we pride ourselves on making the best products in the industry, products that change people's lives. We have won many industry awards for our medical devices, which are sold through hospitals, medical practices, chiropractors, and pain management clinics. We believe that enjoying your work and making valuable contributions to business are equally vital. To that end, Aspen has been designated one of the Best Places to Work in Orange County by the Orange County Register and the Orange County Business Journal eight years in a row.

To meet the basic qualification for this role, you will have legal authorization to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship. In addition, to be a good fit for the Quality Systems Engineer opportunity, you will have:

• Bachelor's degree in Engineering or a related field or a combination of education in a technical field and quality systems experience  
• CQA, CQE or Certified Auditor ISO 13485 highly preferred
• A minimum of 5 years’ work experience in a medical device manufacturing environment in a Quality or regulatory role required  Quick question for you - click here
• Must have:
  • Knowledge of ISO 13485 requirements
  • Experience in CAPA management Quick question for you - click here
  • Internal audit experience and past participation in external audits with regulatory or certification bodies
  • Experience writing audit reports, investigation results, creating presentations and charts with summaries and trending analysis
• Demonstrated understanding of:
  • CAPA management activities
  • Audit strategies
  • Creation of KPIs and trending analysis
  • ISO 13485 and 21 CFR 820
• Basic understanding of 
  • Manufacturing and assembly processes
  • Medical device product lifecycle
  • New EU MDR requirements
  • Statistical techniques
• Proficiency in MS Office Suite programs

In addition, success in this role will require the following core competencies and characteristics:

• Excellent written and verbal communication skills
• Ability to partner with the business and serve as a subject matter expert
• Ability to work independently and collaboratively in a team-oriented environment
• Agility and flexibility to work in areas where ambiguity may exist
• The drive to learn and expand your skills and knowledge

Currently, you will work remotely. Post-COVID, we anticipate working in the office at least part-time. However, as with many things in the current environment, this is subject to change.

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Reporting to the Quality Manager, as Quality Systems Engineer, your primary mission will be to maintain an effective Quality Management System. You will monitor the performance and health of the Quality System, improve processes, and maintain compliance with regulatory and internal requirements.

Working closely with the Quality Manager, you will assist in the creation of Key Performance Indicators as well as the measurement and monitoring of those KPIs. Additionally, you will assist in ensuring compliance to applicable regulatory requirements and internal procedures for Quality Systems such as Document Control, Internal and External Audits, Corrective and Preventive Action, as well as participate in general process improvement activities.

More specifically, you will:

• Establish, maintain, and monitor the status of Quality metrics and KPIs, as well as support the Quality Manager during Quality metric reviews and management reviews  Quick question for you - click here
• Manage and maintain an effective Corrective and Preventive Action program
• Perform internal audits, including report writing, presentation of observations and findings with department managers
• Participate in external audits as a subject matter expert
• Support supplier management activities as they relate to supplier audits, supplier business reviews, supplier corrective actions, and maintain the approved supplier list
• Participate and lead process improvement activities within the Quality department as well as with other department stakeholders
• Perform other Quality related activities as assigned by the Quality Manager, such as training, ECO approval/submission, Post Market Surveillance, and other quality/regulatory activities

This description is intended to give you a general overview of the position and is not an exhaustive listing of duties and responsibilities.

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Autonomy and support
We’ll look to you to achieve goals independently and assume ownership of your areas of responsibility. At the same time, you’ll have support when you need it and plenty of opportunities to collaborate with the Quality Assurance team (located in Irvine and Tijuana). In fact, the Quality Manager's expertise is in quality systems so you'll have a strong mentor when needed. Our goal is to set you up for success, and support you throughout your role.

Build a progressive career
We are proactive about supporting professional development. We offer training that helps employees develop both technical and leadership skills, and we're committed to promoting from within whenever possible.

Award-winning products enhance the quality of people's lives
Backed by over 25 years of R&D, Aspen Medical Products help patients cope with chronic conditions, manage pain, and heal faster (see testimonials in the video on The Role tab). Our innovative approach and strong business model have earned us distinctions. In addition to the workplace excellence awards mentioned above, we have won:

• Several Spine Technology Awards from Orthopedics This Week.
• The American Technology Award, in the medical device category, from TechAmerica Foundation.
• Awards for delivering exceptional service as a vendor, from Hanger/SPS, a leading distributor of orthotic and prosthetic patient care and therapeutic products, services and solutions.
• And others.

Exemplary culture
You will find a close-knit culture that values mutual respect at Aspen. The numerous "Best Places to Work" awards we've won represent high levels of employee satisfaction (as reported by employees) as well as excellence in benefits, pay, work/life balance and culture.

Competitive benefits package
The health, satisfaction and security of you and your family are important to your well-being and important to us. We offer a competitive salary; medical, dental and vision benefits for you and your family; life insurance; paid vacation; and a 401(k) plan with company match. 

Pictured: Just a couple of the many awards we have received.

To excel in this role you will have excellent attention to detail and the ability to help us remain compliant with applicable industry rules and regulations. We have a unique business, and although we are in the medical device space, we are in a lower classification (less-regulated) than many other products you may have experience supporting. This will require the ability to operate with some “gray area” and remain nimble and flexible to meet the needs of our business. If you are coming from a Class II or III background, this could take some getting used to as you adjust to less stringent standards. 

To thrive here, you will need to understand the needs and challenges of the different functional areas and establish yourself as a key resource and subject matter expert. You will partner with others to develop solutions. In addition, to be an outstanding Quality Systems Engineer, you will:

• Be a motivated self-starter with the drive to move things forward and complete tasks
• Establish yourself as a partner and expert who can be relied upon
• Look at things from a value-added point-of-view
• Make risk-based, ISO-based decisions
• Bring a passion for process and improvements
• Work independently, taking ownership of your responsibilities, but also seek help when needed
• Maintain a positive, team-oriented mindset
• Build relationships and work effectively with a variety of internal and external stakeholders and departments
• Remain organized and focused, always knowing what needs to be done

If this sounds like the right mix of challenge and opportunity, and you meet the minimum requirements, we look forward to hearing from you.