SUMMARY: Senior Quality Engineer is responsible for supporting validations, qualifications, risk management, design control and contract review activities for sustaining product lines. Participates in review and approval of documents, resolves quality issues and ensure quality of products and processes, in compliance with all applicable company policies and procedures, as well as, regulatory requirements. DUTIES AND RESPONSIBILITIES: • 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 existing and emerging regulations, standards, or guidance documents. Provide interpretive assistance, to all departments, regarding these documents. • Maintains current knowledge base of applicable statistical techniques, is considered an SME on the utilization of statistics for validation and process capability/performance purposes. • Quality Representative for sustaining Risk Management activities. • Participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified. • Support training on Manufacturing and Quality System documents. • Quality Representative for Material Review Board (MRB). • Develop validation and/or verification protocols; execute validations/verifications and report on the conclusions to support process improvements related to corrective and preventive actions. • Release documents via the change control process as necessary. Train others where required. • Complaint Process owner responsible for maintaining complaint spreadsheet, initiating, tracking and closing complaints. Assist and / or own Quality related complaint investigations, corrective/ preventive actions, etc., as required. • Provides support as the primary Quality representative for Notices of Change (NOCs), Notices of Activity (NOAs), and Nonconforming Material Reports (NCRs) related to sustaining processes. • Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols). • Backup support for RoHS compliance. • Performs Internal Audits in accordance with ISO13485:2016. • Participate in CAPA root cause investigation, actions implementation, and effectiveness checks. • Implement ongoing quality improvement processes working with cross functional teams. • Acts as a consultant for areas related to his/her expertise. • Performs other related duties as assigned by management. 2 SUPERVISORY RESPONSIBILITIES: • This job has no supervisory responsibilities. QUALIFICATIONS: • A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge. • Basic knowledge of ISO 13485:2016 and FDA QSR. • Strong root-cause investigator and problem solver within a manufacturing environment. • Mechanical aptitude with manufacturing experience. • Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos. • Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form. • Well versed in data management and graphical presentation of data. • Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required. • Generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users in the organization. COMPANY COMPETENCIES: • Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassmentfree 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.

Qualifications

JOB COMPETENCIES: • Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics. • Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information. • Validation / Verification - Has a clear understanding of how to design and execute validation and verification activities as they pertain to new product development, process improvements and/or changes. • Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Utilizes data analysis to justify process changes. • 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. 3 PHYSICAL DEMANDS AND WORK ENVIORNMENT: • Occasionally required to stand and walk • Frequently required to sit • Occasionally required to climb, balance, bend, stoop, kneel or crawl • Frequently required to talk or hear • Occasionally work near moving mechanical parts