Job description

SUMMARY
The Quality Engineer II supports the quality evaluation, process documentation, and quality control activities for a mid-sized thermoforming plant, supporting both new product introduction and sustaining manufacturing. Responsible for providing oversight and guidance in manufacturing operations ensuring manufacturing operations are operating under a state of ISO 13485 compliance. The QE will coach manufacturing personnel, on proper Medical device company and procedural compliance and empower them to identify and escalate quality issues, to ensure a quality product.
ESSENTIAL JOB FUNCTIONS

• Establish and direct the project team regarding Quality requirements; provides the most efficient end to end project implementation from part introduction through full production qualification.
• Serves as senior engineer for the quality assurance activities for all current and future medical/ commercial products.
• Enacts and manages Quality elements of transfer to manufacturing to include formal documentation and implementation of process flow, risk analysis (PFMEA), control plans, inspection plans, and measurement fixtures, programming, and equipment.
• Experience on leading and performing Validation activities, including IQ, OQ &, PQ, statistical analysis and test method validation.
• Provides statistical analysis for the associated quality activities
• Update quality systems based on changes to pertinent regulations, audit observations and changes to existing products and processes.
• Create, review, and revise procedures and assist with CAPA investigations as applicable.

Perform data analysis, identify corrective/preventive actions, and implement process improvements with a focus on quality processes.

• Provide input and decision making for quality in the manufacturing areas with regard to manufacturing events and deviations. Provide corrective actions as necessary.
• Manage and perform activities associated with CAPA, Complaints, Non-Conforming Materials, Inspection and Calibration.
• Monitors assigned area(s) for compliance to procedures and cGMPs specific to equipment, documentation, and personnel.
• Support continuous improvement and variation reduction opportunities
• Propose regulatory strategy for new and modified products
• Weekly/monthly reporting (local and corporate teams)
• Develop and establish SOPs according to regulatory requirements
• Oversee qualification and management of overall Supplier base
• Lead others in the quality department through implementation and maintenance of the company quality system, reporting on the performance of the quality system for review and as a basis for improvement of the quality system.
• Engages in direct contact with customers, suppliers, management, internal customers and departments, and regulatory authorities. Communicates effectively in explaining issues, problem resolution, and the need for support/action from others.
• Other duties as required in support of the department and the company

SUPERVISOR RESPONSIBILITIES
This position does not have any supervisory responsibilities
**
**
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential job function 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 and/or EXPERIENCE
Appropriate education and/or experience may be substituted on equivalent basis

• Bachelors and/or advanced degree in a science or technical area or equivalent
• 5 - 8 years of industrial experience, preferably in high volume manufacturing, automation and quality principles within medical device industry with demonstrable skills in machining theory, equipment, tooling, materials, assembly and/or processing
• Medical device experience, ISO 13485
• Knowledge of Lean Six Sigma, Lean Manufacturing principles and tools
• Understanding of the requirements specified by the ISO 13485, OSHA, governmental agencies, and the healthcare industry

CERTIFICATES, LICENSES, REGISTRATIONS

• A CQE is preferred, but not required
• Lean Six Sigma Green or Black Belt certification a strong plus.

LANGUAGE SKILLS

• Ability to read, write, speak, and understand English.

• Proficient written and verbal communication skills.
• Ability to read and understand blueprints.

JOB SKILLS

• Strong data analysis and presentation skills. Proficiency with statistical software, to include MiniTab.
• Able to communicate professionally and effectively with internal and external customers.
• Demonstrates good judgment and decision-making skills
• Ability to work with minimal supervision
• CAD experience in 3D Modeling, preferably Solidworks.
• Ability to be flexible and able to function comfortably in a fast paced, constantly changing, and ambiguous environment while maintaining a positive team environment
• Understanding and experience in Lean manufacturing environment preferred. Participate in continuous improvement projects and 5S related performance teams.

PHYSICAL DEMANDS
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 use hands to finger, handle or feel, and talk or hear. The employee frequently is required to reach with hands and arms. The employee is required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
The work environment described here is representative of that an employee encounters while performing the essential functions of this job. CIT San Diego is a clean facility, housing different machinery, equipment, processes, and chemicals which produce potential hazards in the work environment such as: ergonomic, chemical, machine point of operation, and powered industrial vehicle traffic. These hazards are controlled through means of engineering controls, such as machine guarding, and administrative controls, such as safety policies and programs. In certain areas of the facility, employees are required to wear PPE such as hearing protection, safety glasses, and safety toed shoes.
**
PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS

• ASTM F–2413 rated safety toed shoes
• Clear ANSI Z87.1 safety rated glasses
• Hearing protection, in specific locations

ENVIRONMENTAL POLICY
Carlisle Interconnect Technologies is dedicated to identifying and reducing the environmental impact of its operations, activities, and products. It is our commitment to comply with all applicable laws and other regulatory requirements concerning the environment. We are committed to preventing pollution and continually improving our environmental performance in all our global operations. This will be achieved through a comprehensive Environmental Management System that provides the framework for setting and reviewing environmental objectives and targets of Carlisle Interconnect Technologies.
TRAVEL
<5%
SALARY INFORMATION
In compliance with CA state law, the annual base salary range for this position is $75,000 - $100,000. Please note that the salary information is a general guideline only. Carlisle Interconnect Technologies reviews factors such as but not limited to responsibilities of the position, scope of work, candidate’s work experience, education/training, key skills, internal pay equity, as well as market considerations when extending an offer.
BENEFITS: Health, Dental, Vision, 401k, parental leave, and tuition reimbursement available

Job Type: Full-time

Pay: $75,000.00 - $100,000.00 per year

adamanda.ca is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, adamanda.ca provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, adamanda.ca is the ideal place to find your next job.