Reasonable accommodation may be made to enable individuals with protected disabilities to perform the essential functions of this job.

I.Job Purpose and Core Tasks

The Quality Engineer II is responsible for ensuring that KSEA-OR1’s Quality Management System (QMS) is properly constructed and maintained with applicable global standards.This role supports the development of high-level policies and guidelines to ensure highest quality product and process compliance.

• Interpret FDA, ISO, CSA regulations and develop company compliance that satisfies ISO 13485, the Canadian Medical Device Regulations, and the U.S. FDA cGMP/QSR.
• Maintains knowledge of current and emerging Global Regulatory requirements affecting the business and makes decisions regarding actions necessary to obtain or maintain compliance with applicable regulations.
• Ensures that the QMS continues to improve in alignment with new or revised applicable regulatory requirements standards.
• Develops and maintains new employee quality orientation meeting compliance requirements of the FDA and ISO standards.
• FDA/ISO/Third Party and Internal Auditing
• Supports systematic audits in relation to requirements found in ISO 13485, the FDA Quality System Regulation and any other applicable requirements.
• Supports ongoing preparedness activities in anticipation of routine external audits by FDA, Notified Bodies, and other regulatory agencies. Support company responses to internal and external audit outcomes by facilitating the initiation, assignment, and closure of corrective actions.
• Responsible for addressing opportunities for improvement identified during audits.
• CAPA System Lead
• Initiate corrective actions as needed resulting from audits, complaints and/or other QMS processes or product discrepancies.
• Partnering with impacted groups to determine root cause(s) during CAPA/SCAPA investigation.
• Monitors CAPA/SCAPA timelines to ensure timely completion of resolution, and document closures.
• Tracking and ensuring the effectiveness of the CAPA activities.
• Management Review Designee
• Schedules and hosts quarterly Management Reviews.
• Works with Quality Assurance Specialist to generate all required Management Review documents.
• Conducts follow-up activities on Management Review action items.
• As applicable, provides information to Management, through direct communication and/or special reports, of significant events or issues which could impact compliance levels.
• Post-Production Surveillance
• Initiates complaints in SAP complaint handling system.
• Ensures that the complaints are thoroughly investigated and documented in SAP.
• Prepares the complaints for final review and closure.
• Facilitates trending of service activities to identify trends and propose additional process review and/or corrective action is required.
• Design & Development support
• Participates in product development teams and reviews appropriate design & development deliverables including, but not limited to plans, reports, risk management and design reviews associated with products.
• Approves content of all material change requests by evaluating the impact of the change to ensure requirements per the standing processes are met.
• Continuous Improvement support
• Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to reduce cost and improve the quality of OR1’s products and services.
• Supports Document and Data Control Specialist II in maintenance and improvement of Quality Management softwares/tools.

· Performs other job-related duties or special projects as assigned.

II. Minimum Knowledge, Education and Skill Requirements

Required

Minimum years of relevant work experience: 3-5 years of experience in manufacturing environment.

Minimum education, certifications and/or credentials: A minimum education level of a Bachelor's Degree in Life Sciences, Quality Engineering, Regulatory Affairs, or other discipline

Minimum hard skill requirements (including computer and application proficiency):

o Proficient in the use of Microsoft Excel (graphs, mathematical formulas, linked spreadsheets, importing and exporting, etc.) as well as MSWord and PowerPoint.

o Technical background sufficient to understand devices and medical procedures so that devices and procedures can be explained to FDA and other regulatory bodies.

o Ability to read and interpret regulatory/legal documents and determine the required compliance activities.

Minimum soft skill requirements:

o Organizational and time management skills.

o Ability to multi-task and to solve problems.

o Presentation and negotiation skills.

Preferred

Preferred years of relevant work experience: 3-5 years of medical device manufacturing experience preferred.

Preferred education, certifications and/or credentials: A minimum education level of a Bachelor's Degree in Life Sciences, Quality Engineering, Regulatory Affairs, or other discipline

Preferred hard skill requirements:

o Strong knowledge/background in analyzing quantitative and qualitative data.

o Experience in the generation of process mapping/flowcharting.

o Experience using softwares for Quality Management System activities (accurate analysis and reporting of QMS data)

o Experience with SAP or similar ERP system, preferred

Preferred soft skill requirements: Demonstrated ability to:

o Develop processes, define process controls, and validate process and product performance.

o Lead teams in a consensus building effort towards a defined goal.

III. Essential Function

Must be able to maintain productive working relationships and treat fellow employees with respect.

Has contact with:

Quality department and other departments inside the organization

Other outside professionals (including FDA personnel, consultants, auditors)

Physical requirement/Demands: Light, occasional physical effort

Mental requirements/Emotional Demands:Ability to adapt and demonstrate flexibility in dealing with changing priorities and work situations.

Interpersonal and communication skills:

o Excellent interpersonal, verbal and written communication skills to communicate clearly with manufacturing, purchasing, engineering and internal/external auditors

o Strong customer service orientation

o Ability to work cooperatively with others in a team-oriented environment

o Attention to detail and adherence to SOPs

o Models dependability and works well under pressure

o Ability to maintain accurate and detailed documentation

IV. Core Requirements

Degree of accountability: Generally independent

Degree of decision making: Routine tasks
Financial/Budgetary: Little or no financial impact on revenues or cost

Safety: Adhere to KARL STORZ Safety protocols

Quality: Adhere to KARL STORZ Quality Management System

Supervision: Does not supervise others; requires the ability to work independently with minimal supervision

Authority to Sign (not applicable for North America): N/A

Travel: 25% percent travel required (domestic and international)

Other duties consistent with the general nature and focus of the job and/or the goals and objectives of the department may be assigned.

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