SUMMARY: The Quality Inspector will perform activities to ensure quality control of products and processes, complete and perform review of Device History Records for release of components, sub-assemblies and/or finished goods ensuring records are accurate and in accordance to operating procedures. The Quality Inspector is responsible for the inspection process as assigned; assignation could be receiving, in-process, final release, and/or shipping area.

DUTIES AND RESPONSIBILITIES: • Follows all Good Manufacturing Practices, Quality System requirements and company procedures ensuring quality and regulatory requirements are met in an ethical manner. • Perform inspections of purchased parts, subassemblies and/or finished company products according to defined criteria in product documentation (drawing, specification, procedures, or build packages) by visual inspection and/or using standard physical and/ or mechanical measurements, according to procedures and in a timely manner. • The Quality Inspector is responsible to correctly complete all required documents. One of the responsibilities of this position is verify and ensure accuracy of the data, during the procedure process and at the end of each Lot, ensuring the accuracy of records and maintaining supporting documentation. • Complete the required documentation and certification in a timely manner and with a high level of attention to detail to help ensure product is shipped by their due dates • Perform review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices. • Create the appropriate Certificate of Conformance documents based on the lot history reviews and customer requirements. • Proficient in all quality processes and procedures according to the training matrix. • Collect samples from manufacturing and ship for outside testing purposes • Conduct environmental monitoring where required. • Manage the Quarantine cage activities; verify containment of nonconforming material when needed. • Participate in the construction and/or revision of SOPs for the inspection function. • Evaluate problems and make initial recommendations for possible corrective action to the Quality Manager. • Identify and communicate defects or suspect materials to the Quality Manager in a timely manner. • Work with Production Management and Quality Assurance to provide feedback to assemblers regarding accuracy of assembly procedures. • Maintain order and cleanliness of Quality stations to prevent material mixing. • Maintains a safe and healthy work environment by implementing, maintaining and aligning company policies and procedures. • Correct use of resources of the company such as materials, machines, time and others. • Active member of the continuous improvement team. • Present their area results, plans and improvements when requested. • Participate and assist as a part of the Internal Audit team where appropriate and as requested. • Support Document Control and record management as required. • Other duties as assigned, verbal and written.

SUPERVISORY RESPONSIBILITIES: • This job has no supervisory responsibilities.

Qualifications

QUALIFICATIONS: • High School Diploma or equivalent. • 2+ year of previous experience as in process, incoming or outgoing inspector is preferred. • One year minimum in Medical Devices Industry (Desirable). • Working knowledge of measurement instruments. • Knowledge of Quality Systems documents and general Good Documentation Practices.

COMPANY COMPETENCIES: • Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce. • Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. • Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments. • Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality. • Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

JOB COMPETENCIES: • Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan. • Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed. • Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity. • Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed. • Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.

PHYSICAL DEMANDS AND WORK ENVIORNMENT: • Frequently required to sit, stand and walk • Frequently required to talk or hear • Frequently work near moving mechanical parts • The employee must occasionally lift and /or move more than 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