- Maintain, implement, and audit the QMS including the Quality Manual, Quality Procedures, Work Instructions and Forms.
- Maintain the administration of the Approved Vendor List for suppliers and contract manufacturers. Perform supplier audit when needed.
- Responsible for the company's calibration system in support of all production and developmental testing requirements and maintain calibration records.
- Determine acceptance activities and authors quality control inspection criteria (QCIC) and inspection plan for incoming material.
- Completes measurement system analyses and validates test methods as needed.
- Investigates and resolves non-conformances in collaboration with other functional groups.
- Maintain the company's Material Review Board (MRB), Corrective/Preventive Actions, and Deviation throughout investigation, documentation, root cause, and corrective action activities.
- Administration and technical support of internal and external audits to maintain certification to standards. Familiar with appropriate standards including but not limited to ISO 13485, FDA 21 CFR 820, MDR and IEC 60601
- Oversee product development projects throughout concept to launch from Quality Engineering perspective.
- Technical Writing to document the above essential duties and responsibilities
- Work professionally and collaboratively in a team environment with external and internal stakeholders
- Travel may be required (~10%)
- Other support to QA and RA staff as assigned by upper management.
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QA/QC Engineer - Goleta, United States - True Digital Surgery
Description
* This position is a Product Quality Assurance position AND is 100% On-Site at our location in Santa BarbaraABOUT US
True Digital Surgery is a World Leader in Computer-Guided Microsurgery. We combine 3D visualization and guidance software applications focused on improving accuracy, efficiency and outcomes for surgeons and patients. Our medical imaging and guidance system employs advanced real-time 3D graphic capabilities and proprietary software that is sold to surgeons and hospitals all over the world.
SUMMARY
The QA/QC Engineer will have Quality Management System (QMS) knowledge in a medical device company. The QA/QC Engineer will support senior QA and RA staff assuring the organization, products and processes conforms to all QMS requirements including applicable standards, statutory, regulatory, customer, product and internal requirements and ensures confidence in the quality of our products.
SALARY AND PAY TRANSPARENCY
Salary range for this position is between $90,000 and $95,000. Base pay is dependent upon many factors, such as: training, transferable skills, work experience, education, business needs and market demands. The base pay range is subject to change and may be modified in the future. This role may also be eligible for bonus, equity, and all applicable company benefits.
The salary range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience
Typically requires a Bachelor's degree in Quality or Engineering or similar field of study and 2+ years' related experience in Quality Assurance of medical devices.
Language
Demonstrate excellent communication and documentation skills, both written and oral. Ability to read, analyze, and interpret technical procedures or governmental regulations. Ability to write processes and work instructions. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Math
Demonstrate ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Apply concepts of basic algebra and geometry.
Reasoning
Demonstrate ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills
To perform this job successfully, an individual should have strong computer skills (avid recreational or professional use), knowledge of Microsoft Word, Excel and Outlook.
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 50 pounds and frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include color, distance and close vision.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate.
Benefits:
We value our employees' time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment
To Apply:
To respond to this opportunity, please apply through this ad.
For more information about us, please visit
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
