Overview
Quality Engineer Jobs in Redwood City, CA at i2c inc.
Quality Engineer – Westlake Village,
100% ONSITE
Caldera Medical’s Mission – To Improve the Quality of Life for Women!
Message from the Hiring Manager:
Duties and Responsibilities:
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
Coordinate new process techniques that improve 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 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.
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
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 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 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 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.
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Title: Quality Engineer
Company: i2c inc.
Location: Redwood City, CA
