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Quality Engineer

QA/RA | Agoura Hills, CA | Full Time

Job Description

Position Summary:

The Quality Engineer helps to direct quality assurance efforts to ensure that the company’s products conform to quality and regulatory standards, establishes and maintains quality assurance procedures and controls, and manages the microbiological procedures (sterilization, bioburden, residuals & environmental monitoring).  The Sr. Quality Engineer is responsible for assisting with the Corrective and Preventive Action System (CAPA), Complaint System, Material Review Board (MRB) System, Internal Audit System and Management Review System.  Provides a key role in assuring organizational compliance to the defined Caldera Medical quality system, FDA QSR/GMP regulations, ISO 13485 quality system standards and the Medical Device Directive (MDD) with regard to product development and manufacturing.


  • Serve as a technical resource for the initiation and implementation of cost improvement plans on new and existing programs
  • Perform Validations (IQ, OQ, PQ, MSA, CQ) in accordance with company SOPs
  • Coordinate new process techniques that improves overall job efficiencies
  • Implement quality systems and procedures that assure compliance with Quality Standards
  • Participate in Design Development Process meetings representing quality, where appropriate
  • Facilitate communication between engineering functions, manufacturing, and quality both internally and externally
  • Contribute to the design and development of components, assemblies and devices for various industries
  • Manage equipment and process validation activities for development program
  • Manage acceptance of product & deliverables
  • Participate on development teams, as appropriate
  • Provides direct feedback into product/process quality related decisions
  • Travel to other facilities may be required to support business needs
  • Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction
  • Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality
  • Monitor manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
  • Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
  • Lead generation and completion of protocols and reports for test method validations
  • Interfaces with Manufacturing to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable
  • Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures
  • Ensure that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence
  • Lead and manage complaint investigations
  • Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis
  • Participate in continuous improvement projects
  • Assist with product transfers
  • Work with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems
  • Mentor and support quality inspectors and technicians
  • Performs other functions as required

Minimum Requirements:

  • Bachelor’s degree in a science (microbiology, chemistry, biochemistry) or engineering field; or equivalent mix of experience and education
  • Must have team-centric design/product development experience and minimum of four (4) years quality engineering experience, which may include experience in managing manufacturing quality assurance with demonstrated manufacturing plant experience
  • Capacity to manage multiple projects and/or challenging projects with many unknowns and to manage time effectively to ensure timely completion of tasks
  • Understanding of the project development process, associated terminology, and quality system requirements
  • Ability to effectively present information and respond to questions from all levels of an organization internally and externally
  • Strong communication (verbal and written), teamwork and organizational skills, with a proficiency in Technical Writing
  • Ability to identify problems, develop and implement actions for resolution
  • Ability and experience mentoring peers as well as junior engineers
  • Demonstrated track record of project accomplishment
  • Demonstrated track record of planning activities with contingency actions
  • Competence in the selection and use of Quality Engineering Tools and Techniques.
  • Solid knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.)
  • Proficiency in Microsoft Office and Minitab
  • Ability to work independently and in team environment


About Caldera Medical:

Caldera Medical is a growth stage medical device company focused on designing, manufacturing, and marketing products into the Gynecology, Urology and Urogynecology surgical markets.  We are searching for highly motivated, dynamic and results oriented individuals to join us in improving the quality of the patients we serve.


The Culture:

  • A Culture of family and team…not a corporate goliath where you’re just another number
  • All employees get a seat at the table and have influence with management
  • Women’s Health Initiative - Giving back to those who can’t afford treatment 
    • Goal to treat 1 million women suffering from incontinence by 2025!

The Benefits:

  • Competitive Compensation
  • Basic Life and AD&D
  • Unlimited Vacation
  • 6 Weeks Paid Maternity Leave
  • Kitchen stocked with free snacks and drinks
  • Being surrounded by talented and engaged employees
  • Medical / Dental Benefits – 75% paid for employee and family members
  • 401(k) with 4% matching contributions

Learn more about us on Glassdoor -

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.