Engineer II - QA

Arthrex GmbH; Pendleton (SC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

401(k) Retirement Plan

Annual Bonus

Free Onsite Lunch

Tuition Reimbursement Program

Paid Time Off

Employee Assistance Program (EAP)

Job summary

Arthrex, Inc. is seeking a Quality Assurance Engineer II for our Pendleton, SC manufacturing location. You will support the Quality Manager in lifecycle development of Class I-III medical devices, including new product development and maintenance of released products.

Responsibilities include leading or supporting FAI inspections, CAPAs, risk assessments, supplier quality, audits, and continuous improvement initiatives. A BS in engineering with 2 years in medical device quality is required.

Qualifications

• Bachelor's degree in Engineering or Engineering Technology.
• 2 years experience in quality roles within medical devices.
• Experience with Design Controls, GD&T, and DOE.
• Knowledge of SPC and risk assessment tools.
• Strong communication across cross-functional teams.

Responsibilities

• Review design drawings for tolerance, inspect-ability and quality issues.
• Collaborate with suppliers to improve quality and assist in supplier validations.
• Train QC Inspectors on inspection techniques and new equipment.
• Lead or participate in internal/external quality audits.
• Support risk management, PFMEAs and risk assessments.
• Assist in AMI Engineering Change Management tasks.
• Lead/participate in First Article Inspection processes and related reports.
• Lead/Support equipment or process validation (IQ, OQ, PQ).
• Lead or support Metrology in inspection methods and gages.
• Create/Review inspection method work instructions.
• Lead/Support MSA (Gage R&R) studies.
• Create inspection plans for receiving and in-process inspection.
• Investigate complaints with the Reliability team.
• Close NCRs with disposition plans and CAPA actions.
• Perform QC trending and quality review meetings.
• Lead Continuous Improvement projects.
• Support Environmental Monitoring program.
• Complete Root Cause Analysis and CAPA actions.
• Conduct DOE studies as needed.
• Perform other duties.

Skills

Quality Assurance

Design Controls

GD&T

DOE

Process Validation

SPC

Lean Six Sigma

Kepner-Tregoe

5 Whys

Communication

Education

Bachelor's degree in Engineering or Engineering Technology

Tools

Excel

Minitab

SAP

Agile

Pilgrim QMS

Job description

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 a Quality Assurance Engineer II for our Pendleton, SC manufacturing location. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Main Objective:

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.

Essential Duties and Responsibilities:

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

Education and Experience:

• Bachelor's degree required Engineering or Engineering Technology discipline required.
• 2 years experience required, preferably in a Quality Control or Quality Assurance position in a Medical Device Company.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

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

Machine, Tools, and/or Equipment Skills:

• Proficiency 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.
• Knowledge of measurement and other inspection equipment.
• Manufacturing process knowledge.

Reasoning Ability:

Ability 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:

Ability 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:

Ability 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:

The 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:

Visual acuity necessary to do the job safely and effectively.

Specific vision abilities required by this job include close vision using a microscope and light source.

The 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.

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive ProgramFree Onsite Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Time Off
• Employee 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 law.