Quality Engineer

100% ONSITE

Message from the Hiring Manager:

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 microbiological procedures (sterilization, bioburden, residuals & environmental monitoring). The 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 with 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.


Desired Knowledge, Skills and Abilities:

• 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.
• Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• Lead and manage complaint investigations.
• Lead generation and completion of protocols and reports for test method validations.
• Represent Quality in Design Development Process meetings; monitor manufacturing activities for compliance with DMR and support deviation/waiver guidance; collaborate with Manufacturing to review and validate processes for new and existing products, ensuring complete and accurate Device History Records and recommending process monitoring tools as needed.
• Participate in development teams activities, 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.
• 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.
• Collaborate cross-functionally with suppliers, management, engineers, and manufacturing associates to identify, investigate, and resolve quality issues, driving continuous improvement and ensuring compliance with quality standards.
• Mentor and support quality inspectors and technicians.
• Must be able to sit or stand for extended periods and lift up to 20 pounds as needed to support job functions.
• Performs other functions as required.

Required Knowledge, Skills and Abilities:

• 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 3 years quality engineering experience, which may include experience in managing manufacturing quality assurance.
• 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 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, 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 a team environment

Our Culture- Where Career and Passion come together!

• 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. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
• The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.
• Our goal is to treat 1 million women suffering from incontinence by 2027!

Competitive Compensation, Comprehensive Benefits, and more!

• Annual Salary - $90k
• Medical and Dental Benefits – 75% paid for employee and family members
• Vision Coverage
• 401(k) with 4% matching contributions after 90 days of employment
• Basic Life and AD&D
• Unlimited Vacation Policy
• 6 Weeks Paid Maternity Leave
• 10 paid holidays- including your birthday!
• Being surrounded by amazing people!

Who is Caldera Medical?

Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.

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.