Requisition ID:

66487

Title:

\nSenior Engineer - QA Manufacturing Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for Senior Quality Assurance Engineer for our manufacturing facility in Ave Maria, FL. The Senior Quality Assurance Engineer is responsible for supporting the Quality Manager with all quality related support for the life cycle development of Class I, II and III medical devices, including new product development and maintenance of released products. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better.

Essential Duties and Responsibilities:

Review design drawings for tolerance, inspect-ability and quality of design issues.\nWork with suppliers to improve quality, and assist, where necessary, in supplier process validations.\nAssist in the training of QC Inspectors on inspection techniques and the use of new equipment.\nParticipate in Internal and External quality audits as directed by the Quality Assurance Manager.\nSupport Risk Management by leading or participating in cross-functional team pFMEA's and Risk Assessments.\nSupport the AMI Engineering Change Management process by performing tasks as assigned.\nLead or Support the internal manufacturing First Article Inspection process, review First Article Inspection Reports and samples (internal and/or supplier).\nLead or Support equipment or process validation (IQ, OQ, PQ)\nLead or support Metrology with design and development of inspection methods and gages.\nCreate or review inspection method work instructions.\nLead or support Metrology with Measurement System Analysis (Gage R&R) studies.\nCreate Inspection Plans Supporting Receiving and In-Process Inspection.\nInvestigate complaints as requested by the Complaints/Reliability team.\nLead completion of Nonconformances (NCR's) as assigned: material disposition plans, evaluations, and action plans.\nPerform routine Nonconformance and process trending and lead periodic Quality review meetings with the management team.\nLead or Support Continuous Improvement projects.\nLead or support the Environmental Monitoring program.\nComplete Root Cause Analysis Investigations and define Corrective/Preventive Action Plans (CAPA's).\nPerform Engineering Studies and Design of Experiments (DOE) as needed.\nOther duties as assigned.

Education and Experience:

Bachelor's degree in Engineering required\n5 years quality engineering experience in a highly regulated industry required Knowledge and Skill Requirements/Specialized Courses and/or

Training:

Technical knowledge in development methodologies including: Design Controls, GD&T, DOE, Process Verification and Validation.\nSPC (Statistical Process Control) knowledge.\nWorking knowledge of process improvement tools (i.e.: Lean - PDCA, Six Sigma - DMAIC) and problem solving (i.e.: Kepner Tregoe, Lean A3, 5 Whys) preferred.\nWorking knowledge of risk assessments, PFMEAs, control plans, quality plans.\nStrong communication skills and ability to communicate effectively with technical and non-technical staff.\nProject management skills preferred. Machine, Tools, and/or

Equipment Skills:

\nProficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), miniTab or similar statistical analysis software, SAP or similar inventory software, Agile or similar design lifecycle software, Pilgrim or similar QMS software.\nKnowledge of measurement and other inspection equipment.\nManufacturing process knowledge

Reasoning Ability:

\nAbility to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Mathematical Skills\nAbility to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. Prefer working knowledge and application of Statistics.

Language and Communication Skills:

\nAbility to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Physical Demands:

\nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the 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 talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.

Vision Requirements:

\nVisual acuity necessary to do the job safely and effectively.\nSpecific vision abilities required by this job include close vision using a microscope and light source.

Work Environment:

\nThe 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. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate. Arthrex Benefits Medical, Dental and Vision Insurance\nCompany-Provided Life Insurance\nVoluntary Life Insurance\nFlexible Spending Account (FSA)\nSupplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)\nMatching 401(k) Retirement Plan\nAnnual Bonus\nWellness Incentive Program\nFree Onsite Medical Clinics\nFree Onsite Lunch\nTuition Reimbursement Program\nTrip of a Lifetime\nPaid Parental Leave\nPaid Time Off\nVolunteer PTO\nEmployee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by 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Senior Engineer - QA Manufacturing