Entry Level Method Validation Jobs (NOW HIRING)

Summary: Quality Technician will drive a Culture of Quality and Continuous Improvement within the company by promoting adherence to the Quality System requirements across all departments. Quality Technician is responsible for ensuring customer, company, and regulatory requirements are met or exceeded while simultaneously meeting company cost and productivity goals by supporting Development and Manufacturing with the development, improvement and qualification of manufacturing processes and developing inspection processes. Quality Technician is the key inspection team associate carrying out inspection plans and methods to ensure products meet customer requirements, and Quality cost are contained. Quality Technician is also responsible for identifying, documenting, communicating quality issues (e.g. nonconformances, press set up first piece results, in-process measurement results, etc.). Quality Technician also provides cross-functional quality technical support to the owners of key support functions including but not limited to, Quality Engineering, supplier management, change management, equipment/tooling control including die qualification, calibration and preventive maintenance. Quality Technician may occasionally provide support to the Quality System Compliance function by providing subject matter expertise during internal, supplier and external audits.

Quality Technician is stratified into different skill levels of advancement:

Level I: Entry level with basic skill set, requires close oversight and management of work by more senior Technicians or Quality Management. Responsible for completing inspections and associated documentation as assigned. Requires management and oversight of work.

Level II: Proficient in measurement equipment set-up, adjustment, and alignment as well as a demonstrated ability to create programs and develop work instructions for visual inspections. Able to support training within the organization for GD&T and Inspection requirements. Participates in development of tooling and inspection methods. Works with Customer Focused Teams, and Production Focused Teams to create and execute inspection programs and related documentation. Supports and executes Test Method Validation for inspections per Test Method Validation Protocols under the direction of the Level III or Lead Technician. May participate in investigation of product and process issues utilizing problem solving skills to identify issues and actions required. Is able to work more independently with some oversight.

Level III: Has extensive knowledge of dimensional metrology, GD&T, and has the ability to read and interpret blueprints. Understands risk associated with critical to quality requirements. Works with Customer Focused Teams, and Production Focused Teams to create and execute inspection test methods and programs and related documentation. Supports the development, coordination and execution of Test Method Validation for inspections per Test Method Validation Protocols. Proficient written skills with ability to transform abstract information into logical, sequential instructions appropriate to the level of the intended user. Demonstrated problem-solving skills and technical writing skills. Able to communicate at all levels within the organization, with customers and with suppliers. Minimal oversight is required by this position with employee showing a self-directed work style and leadership within and outside of the Quality Group. Demonstrated risk-based decision-making in support of organizational goals and documented customer target performance. Employee actively improves processes and customer satisfaction.

Technical Lead: A non-advisor role. Subject matter expert in dimensional metrology, including GD&T, and development of inspection methodologies and equipment. Works with Quality Technician Team, Customer Focused Teams, and Production Focused Teams to develop, create and execute inspection programs and related documentation based upon inspection plans with acceptance and rejection criteria. Understands company and regulatory requirements for medical device products commensurate with the metrology and inspection team activities and demonstrates the ability to balance these requirements along with meeting customer expectations and company expectations. Provides troubleshooting for measurement challenges. Provides mentorship, and training on measurement equipment and programming, for other members of the Quality Technician team. Ensures that failure investigation methods are employed to resolve issues encountered, and ensures documentation is accurate, complete and compliant with company procedures.

Group Lead: The Quality Technician Group Lead is a working Advisor position, responsible for leading Quality Technician teams across all shifts to meet or exceed Innovize goals for Safety, Quality, Delivery, Pipeline and

Revenue. While performing in the role of Quality Technician III, the Group Lead also advises Quality Technician Associates, ensuring the associate's development. Able to navigate ambiguity, problem solve and make timely responsible decisions, while working under pressure. The Group Lead Quality Technician ensures the Quality Technician team has all necessary resources to successfully perform their job in the execution of quality plans and assists the Quality Engineering Manager in establishing training matrices for the Quality Technician team.

Technical Group Lead: The Quality Technician Technical Group Lead is a working advisor role that combines both the Technical Lead and the Group Lead roles into one position. All of the duties described for the Technical Lead and Group Lead apply simultaneously.

Duties/Responsibilities include but are not limited to:

• Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner.
• Meets commitments on time with accuracy and attention to detail.
• Maintains current knowledge base of applicable medical device regulations (FDA QSR, ISO 13485, ISO14971) and other associated standards or guidance documents.
• Based on assignment, will perform the following activities:
  • Set-up, adjust, align, and run complex inspection equipment including Coordinate measuring machines (CMM).

• • Conduct component first piece, and assembly inspections per inspection documentation which includes visual and dimensional inspections using standards and inspection tools
  • Collect and analyze data using software programs
  • Calibrate equipment
  • Identify, create and triage nonconformances and document in Epicor according to company procedures
  • Perform evaluation of returned goods
• Creates and runs CMM programs
• Performs inspection per documented inspection plans and test methods.
• Develops control plans and inspection methods from estimates, engineering drawings and other specifications to determine acceptance and rejection criteria
• Supports failure investigations
• Participates in continuous improvement and Lean initiatives
• Performs other related duties as assigned by management.
• Participates in the development and conduct of training for visual and dimensional inspections. Supports other Quality training as assigned.
• Assists with equipment and method qualifications

Training/Education/Experience

• High school diploma required
• Technical program certification (e.g. ASQ-CQT) or Associates Degree in Quality Technology preferred
• Proficient with Microsoft office software, especially Excel and Word. Computer skilled and able to learn Quality Software Systems including Epicor and Master Control.
• Ability to read and interpret basic to moderately complex engineering drawings and specifications
• Familiarity with inspection tools including CMM type equipment
• Understanding of GD&T principles

Quality Technician Experience:

Level I: at least 1-year experience in a manufacturing environment preferred, may substitute technical certificate in lieu of 1-year experience.

Level II: at least 2-years as a QT 1, or equivalent experience, or ASQ-CQT with 1-years' experience as a QT 1

Level III: at least 2-years' experience as a QTII, or Associates Degree in related field, an at least 2-years' experience in a manufacturing environment including knowledge of CMM programming

Technical Lead: >1-years' experience as a QT III plus demonstrated expertise in multiple areas of Metrology

Group Lead: Greater than or equal to4-years' experience as a Quality Technician at least one year at the level of a QT III, with training and/or experience in group supervision

Technical Group Lead: >1-years' experience as a Technical Lead. Plus Greater than or equal to 4-years' experience as a Quality Technician at least one year at the level of a QT III, with training and/or experience in group supervision.

Physical Requirements:

• Vision correctable to 20/20 with normal color vision (where inspection criteria requires color discernment)
• Technical aptitude to work with equipment and inspection tools including but not limited to calipers, microscopes, and CMM type equipment
• Regularly required to sit as well as climb or balance, stoop, kneel and crouch.
• Must be able to work in manufacturing environments exposed to moving mechanical parts and restricted gowning requirements.
• Must occasionally lift and/or move up to 25 pounds.

Competencies/Talents/Personal Attributes

• Well-developed written and verbal communication skills in English. Ability to effectively present information to all levels within the organization, regulators, and customers
• Results oriented, self-starter, who can simultaneously work independently and as a high-performance-team member
• Strong attention to detail
• Very organized and able to maintain organized records
• Proficient with Microsoft Office software and familiar with CMM program execution and programming and GD&T software (SmartProfile, Measure-Fit)
• Able to create graphs and tabulate data
• Ability to prioritize and drive multiple activities and adapt to changing business needs;
• High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal supervision.
• Able to explain complex/technical matters;
• Technical aptitude to work with equipment and tools including measurement equipment such as calipers, microscopes, and test equipment.