The RequirementsTo be a good fit for the Senior Quality Engineer opportunity you should have:
- A bachelor's degree in Engineering or an equivalent combination of education and directly relevant experience. Certified Quality Engineer (CQE) is preferred.
- 5+ years of quality control experience in a regulated manufacturing environment; Class I or II medical device experience is strongly preferred.
- A basic understanding of regulations, ideally including QSR and ISO for medical devices.
- New product development knowledge.
- Internal auditing experience.
- Proficiency in MS office, including Excel.
- Familiarity with MRP systems, preferably including IQMS.
- The ability to:
- Use calipers, micrometers and other basic inspection gages and instruments in the measurement process.
- Read and understand specifications and simple part drawings.
- Work in a team environment and to problem-solve when things are not working per the intended methods.
- Bilingual skills in English and Spanish would be a plus.
The RoleReporting to the Quality and Regulatory Manager, you will join a team that also includes an Associate Engineer. You also will interact quite a bit with our team of Quality Inspectors, as well as with quality professionals in our Tijuana location.
You will assume responsibility for managing and maintaining several Quality Management System processes to ensure the processes are robust and in compliance with regulatory requirements. Inspections are conducted by two Quality Inspectors and a Quality Specialist in the manufacturing department, so you will focus on quality control processes and practices.
Your key activities will fall into three main areas:
- Managing all processes around nonconforming materials, complaints and return merchandise authorizations (RMA), including testing, documentation and compliance.
- Supporting the Quality Control Inspectors through training, inspection procedure generation and guidance.
- Assisting in the testing, qualification and validation of new products and processes as well as those necessary to support engineering change orders (ECOs).
More specifically, you will:
- Assume full responsibility for the management of the nonconforming material process (MRB). This will include coordination with other functional areas to determine usability, testing and evaluation and final disposition of nonconforming material. You'll also document the MRB activity in the MRB process and ensure compliance with organizational and regulatory requirements.
- Assume full responsibility for the review, processing and closure of the RMA Complaint process. This will include review and verification of alleged issues, determination of root cause and population of the complaint database. You'll perform monthly and quarterly analysis of complaints, identifying any trends and areas requiring action. You also will participate actively in monthly metrics meetings and Quality Management reviews.
- Establish and review Quality Control inspection procedures to support existing and new product requirements, including training and identification of necessary tooling and equipment.
- Support new product development through identification of qualification and validation criteria to support the development, testing and release of new products into the production environment.
- Create monthly quality metric reports for the Quality Manager for specific Quality processes.
- Support the Internal Audit process through leading or assisting internal audits as assigned.
- Support ongoing Production for Quality issues as needed.
- Support the Corrective Action process as required through assisting other functional areas in root cause determination, implementation plan and implementation.
What's in It for YouStrategic impact
This role includes day-to-day responsibilities, but you also will play an important role in raising the bar with regard to quality methods and practices. Our President often emphasizes that quality is #1, not only in our products, but also in our culture. Also, on a more tangible level, you'll help support ISO certification efforts.
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 and resources whenever you need them. For example, the Inspectors are seasoned, having at least 6 and some more than 20 years of experience. They will be a strong source of information about our products.
We support our employees' efforts to learn and grow, offering a variety of training and development opportunities. In addition, success in this role could set you up to pursue different career paths within our company, particularly as we grow and evolve.
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.
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.
Our Employee Council puts together a variety of events that enhance teamwork and allow us to have fun. We might go to see the Angels play, go bowling or spend the day at Knott's Berry Farm. Your family is enthusiastically invited to these events and each event is 100% paid for by the company. The destinations for our annual "guest invited" company trips vary. We might head for Palm Desert, Las Vegas or Santa Barbara . . . or maybe you'll suggest a destination. We also get involved in community and philanthropic activities, as you can see in the video.
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.
Video: Aspen Medical Products has been involved with the Challenged Athletes Foundation since 2000. Through donation, fundraising and volunteering, Aspen employees unify to support the CAF in numerous ways. Since 2009, Aspen has held the privilege of being the title sponsor of the Aspen Medical Products San Diego Triathlon Challenge.
Keys to SuccessOur approach to quality is not to act as police or view everything in black and white. To excel here, you will need to understand the needs and challenges of the different functional areas and establish yourself as a resource. You will partner with others to develop solutions.
While we always have paid close attention to quality regarding our products, we are in the process of integrating a quality mindset across the company, including business processes, for example. You'll need to strike the right balance between handling the daily tasks and supporting efforts to embed a quality mindset into our overall culture. Our organization is always evolving and you'll need to be comfortable dealing with ambiguity from time to time.
About UsTruly Innovative Patient Care for the Upper and Lower Spine
Founded in 1993, Aspen Medical Products is a leader in the design, development and marketing of upper and lower spinal orthotics. The Company is located in Irvine, California and has sales representatives throughout the United States as well as representation worldwide. For over twenty years, the management team and employees at Aspen have introduced a continuous flow of pioneering spinal bracing products and services to the healthcare marketplace.
We make the best spinal braces in the world and run a company we can be proud of.
Goals from the Beginning
- Develop the best products in the industry.
- Develop products that enhance the quality of life.
- Have a culture where employees are respected, have input, and are part of the team.
- Be a company where employees look forward to coming to work each day.