Job Description
I. POSITION SUMMARY
- The Engineer IV, Quality position will provide quality engineering support for both sterile and non sterile products.
- The position will work primarily with KARL STORZ s Advanced Machining Center (AMC) and Single Sterile Use (SSU) production to ensure that product meets all necessary quality and sterility requirements to support patient safety and compliance to applicable regulations.
- The Engineer IV, Quality role will provide sterilization expertise and routine assessment of sterilization release processes.
- It willl also be responsible for performing various Quality Engineering activities whose main purpose is to facilitate continuous improvement for both products and processes and to support new product/process development activities.
- These activities include, process validation, defect analysis, corrective and preventive action, problem solving activities related to products and processes, performing internal audits to verify compliance with ISO and FDA Regulations, supporting external audits, and developing and implementing test and measurement techniques. Responsible for the supervision of technicians, as applicable.
II. MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS
• B.S. Degree in an Engineering discipline.
• 5 years minimum experience in manufacturing and Quality Assurance of medical devices.
• Sterilization and clean room knowledge and experience preferred.
• Machining and machine shop environment.
• Injection molding experience preferred.
• Strong and proven experience with basic statistics, SPC and quality engineering concepts.
• Proficient in MS Office software including Word, Excel, Outlook, and PowerPoint.
• SAP experience a plus. SSBB/SSGB and Minitab experience a plus.
• Ability to communicate effectively with personnel at all levels both verbally and in writing.
• A self-starter able to function independently with minimum direction and to act on behalf of the Manager of Quality Assurance in his/her absence.
• Excellent organization skills with the ability to perform multiple tasks and obtain results working within strict time frames
III. ESSENTIAL FUNCTIONS
A. PHYSICAL REQUIREMENTS:
• Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
• Should have sufficient visual capacity to make judgments concerning the quality of components, subassemblies and/or finished products.
• Work time will be spent in a standard office environment along with manufacturing plant and clean room exposure.
• Personal protective equipment is required on the production floor. Standard, designated gowning is required in the clean room.
B. MENTAL REQUIREMENTS:
• Must be an independent worker, capable of meeting goals and objectives as defined by Management.
• Must have sufficient judgment to make reasonable business decisions concerning quality issues with regard for both economic and quality aspects.
C. DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.):
• All employees are expected to be knowledgeable about and follow the Company s Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
• Be knowledgeable in FDA, ISO, MDR regulations as applicable.
• Lead company initiatives related to quality systems improvements/changes or technical improvements/changes.
• Write/execute process validation protocols.
• Lead and/or participate in efforts to implement new/revised regulatory standards.
• Lead and/or support problem solving activities and Six Sigma initiatives.
• Lead and/or support lean manufacturing and continuous improvement efforts.
• Develop key quality metrics related to products/processes, and analyze quality data.
• Lead or participate in performing internal and supporting external audits of products and processes.
• Preparation of test and inspection procedures.
• Preparation and review/approval of Engineering Changes.
• Provide training and direction to manufacturing and QA personnel.
• Participate in MRB meetings.
• Perform system and component defect analysis in conjunction with the risk management and continuous improvement programs.
• Meets and enforces all department and company regulations (e.g. quality, performance, attendance, teamwork, productivity, etc.)
• Responsible for ensuring that product meets all necessary quality and sterility requirements, as applicable, to ensure patient safety.
• Ensures that robust environmental monitoring process controls are maintained.
• Assure appropriate actions are taken relative to the release or quarantine of sterilized product.
• Evaluate changes in products per organizational risk management practices to ensure effective, safe and complaint devices are released to the market in accordance with current state and federal standards.
D. ENVIRONMENT, HEALTH AND SAFETY:
• Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations, including the Company s environmental and safety policies and procedures. Must be willing to report actual and potential environmental and safety violations to appropriate supervisory and/or management personnel.
• The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001.
• Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others.
• Responsible for informing the Company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties.
• Responsible for acting on the information provided to him or her by subordinate employees by recording information and promptly pursuing resolution of any identified problems.
E. QUALITY:
• The incumbent in this position is responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, ISO 13485 (current revision).
• Responsible for advocating following various regulations and using quality tools for problem solving/analysis.
F. INTERPERSONAL AND COMMUNICATION SKILLS:
• Must be able to maintain productive working relationships with subordinates and co-workers.
• Must treat fellow employees with respect.
• Must be capable of communicating effectively with peers, subordinates and superiors within and outside the QA department, as well as with KARL STORZ customers in regard to product issues.
• Must demonstrate a calm and rational disposition while remaining firm as required in dealing with others on issues of a controversial nature.
• Able to prepare written reports in a professional manner.
• Able to prepare and give presentations at all levels of the organization.
IV. OTHER FUNCTIONS
A. OTHER DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.):
• Participate in the Design Control process for new products including Design Review, Quality Planning, Equipment Selection, and Qualification Testing.
• Coordinate and conduct qualification test programs at outside facilities.
• Qualification of new components and processes.
• Design and implement test and inspection equipment.
