Sr. Quality Engineer

Job Description

Sr. Quality Engineer

Caldera Medical's Mission - To Improve the Quality of Life for Women!

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 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.Responsibilities:

• 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

Duties:

• Shelf-life testing for current products.
• Shelf-life updates.
• Labeling
• Equipment and Calibrations
• Perform lot or other quality testing/inspection as needed.
• Environmental monitoring
• Manufacturing document revisions as needed
• CA/s, NCRs, Waivers, Deviations as needed
• Complaint investigations
• Quality/Vendor audits

Qualifications:

Education:

• Bachelor's degree in engineering (mechanical, electrical, bio-medical, or related field), and a minimum of 5-7 years of experience in Quality Engineering in a regulated medical device or pharmaceutical industry.

Or

• Master's degree in engineering (mechanical, electrical, bio-medical, or related field), and a minimum of 2-5 years of experience in Quality Engineering in a regulated medical device or pharmaceutical industry.

Certifications:

• Six Sigma Green Belt or Black Belt (preferred).
• ASQ Certified Quality Engineer (CQE) or other relevant certifications (preferred).

Skills & Knowledge:

• Deep knowledge of FDA regulations (21 CFR Part 820), ISO 13485, ISO 14971, and other applicable standards.
• Strong understanding of risk management methodologies (FMEA, risk analysis).
• Experience with design controls, validation/verification, and process validation.
• Proficiency in using quality tools such as CAPA, root cause analysis, and statistical process control (SPC).
• Familiarity with document control and change management systems.
• Excellent communication and problem-solving skills, with the ability to work cross-functionally.
• Proficiency with Microsoft Office Suite and Quality Management Software (QMS) tools.
• Experience with medical device manufacturing processes and understanding of sterile and implantable devices.

Competitive Compensation, Comprehensive Benefits, and more!

• Salary $115,000 annually.
• 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.

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 2025!

Hear it from our very own! Learn more about Caldera onGlassdoor

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.