Job Description

Quality Specialist Medical Devices

Quality Specialist Medical Devices

Located in Southern California, Overture Orthopaedics is a funded, revenue-generating, dynamic medical device startup opening new markets to treat focal cartilage defects and injuries in the cutting-edge world of sports medicine and orthopedics.

Our company consists of inspired employees passionate about improving the quality of life for millions of patients impacted by joint pain through minimally invasive surgical solutions, and we love to solve challenging problems for our priority stakeholders : patients.

As a Quality Specialist, you will be responsible for inspection, process validation, final release of product, distribution of product, and handling product returns to ensure our solutions maintain the highest quality standards of Overture.

These responsibilities also include compliance with our Quality System policies and procedures and all applicable external requirements and standards, including FDA Title 21 CFR Part 820, ISO 13485 and other worldwide agencies.

You will report to the Chief Executive Officer and interface directly with cross-functional leads across the company. This is an onsite role at the company’s headquarters in Irvine, CA.

To learn more, visit our website :

Essential Responsibilities / Functions :

Collaborate with internal (Product, R&D, Supply Chain, Inventory) and external partners (laboratories, manufacturers and packagers, et al.

to provide best-in-class medical devices that meet quality and regulatory requirements for new and existing products.

• Lead management and execution of an efficient and effective product acceptance process, including performing against inspection instructions and equipment, as well as confirming vendor conformity with our quality procedures and documentation.
• Ensure individual and corporate compliance with all Federal, State, and Local laws and regulations, as well as Overture policies and procedures.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues with inspection and distribution.
• Maintain and operate the current document control system, while continuing to analyze, review and refine our quality systems, platforms, processes and planning.
• Evaluate and support any Corrective and Preventive Action activities and non-conformance investigations, should they arise, as well as any complaint filings / notices.
• Work closely with R&D and are design and manufacturing partners to support new product development and lead quality assurance for existing products.
• Collaborate with internal and external partners to handle documentation and processing of returned product including identification, segregation, and disposition of returned product utilizing the appropriate processes such as the complaint and / or nonconforming processes.
• Maintain accurate records and actively comply with Overture’s Quality System.
• Create and communicate reports to senior executives on all quality-related items.
• Overture is a startup entrepreneurial environment, and we provide each employee the opportunity to assist in work areas outside of their traditional or typical scope.

We are fast but deliberate, and you will be expected to contribute across the organization.

Preferred Education and Experience :

Four-year B.S. degree, ideally in an Engineering and / or Technical field preferred; in the alternative, 4-8 years’ experience in a related field is acceptable

Skills and Abilities :

The ideal candidate will possess the following qualifications :

• A passion for helping others through medical device solutions a desire to improve the lives of our patients.
• Solid experience in quality, manufacturing and / or Engineering / R&D in the medical device field.
• In-depth knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies, as well as an understanding of FDA 12 CFR 820 and ISO 13485 quality requirements.
• Aptitude to navigate and utilize electronic systems used by Overture, ideally familiar with QCBD and NetSuite.
• Team-oriented individual with strong interpersonal and communication skills, ideally with some experience in a start-up environment.
• Excellent organizational skills, and a good blend of discipline and creativity.
• Critical thinking and the ability to identify and then quickly solve for errors or deficiencies in product or process.
• Excellent organizational and time management skills to structure work and projects to achieve timely progress on multiple simultaneous tasks, meet deadlines, and maintain a high level of productivity.

Compensation & Benefits

The starting base pay range for this position is $125,000 $150,000 annually. Base pay will vary based on job-related knowledge, skill and experience and may also depend on the overall job market.

In addition to base pay, we offer a competitive compensation bundle that includes a robust benefits package.

Overture Orthopaedics offers health care benefits such as medical, dental, vision, and you’ll also have flexible PTO, with a potential for bonuses, equity and more!