About Us:
How many companies can say they’ve been in business for over 177 years?!
Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!
What’s the role?
The Senior Quality Engineer provides engineering support for the Company’s quality systems, ensuring compliance with ISO 13485, CFR Title 21 Part 820, and design control standards. It also provides product engineering support by assessing risk and process capabilities, along with developing and implementing effective quality assurance controls. Using a “hands-on” approach to continuous improvement of the quality system and implementation and Quality Assurance management of the design control process, problem-solving, problem investigation and data mining.
Here’s what you’ll do:
• Collaborates with manufacturing engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Use knowledge of statistics on acceptance criteria, DOE, and comparison testing to support development engineers in the development of compliant test plans and reports to meet regulatory requirements and quality objectives.
• Supports manufacturing continuous improvement and development as the Quality team member for validation including IQ, OQ, PQ, and test method validation.
• Generate and/or apply statistical methods with appropriate risk-based justification.
• Track nonconforming material and leads Material Review Board (MRB) efforts. Interface and take the lead QA role in interactions with suppliers, contractors, and consultants that supply components, subassemblies, and contract processing.
• Support complaint investigations on the returned product. Manage corrective action and quality improvement activities.
• Support risk assessment processes for manufacturing and development including FMEA, ensuring risk assessments are thorough and documentation meets all governing requirements.
• Define critical quality characteristics and inspection plans for components, subassemblies, and finished devices.
• Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
• Maintain expertise in both current and emerging requirements and quality trends as they relate to medical device products worldwide.
• Facilitate group meetings and project leadership that drive to comprehensive technical solutions for multiple issues and projects simultaneously.
• Ensure internal quality processes, procedures and systems are compliant with all governing standards.
• Participate in and assist with internal audits. Supporting in corrections needed or CAPA that may result from the Audits.
• Manage, and measure the effectiveness of the Corrective and Preventive Action Processes including Internal and External Audit Processes.
• Support Quality Manager during notified body audits and recertification audits.
• Report key metrics and trends to top management such as non-conformances, deviations, and CAPAs in weekly meetings.
• Independently provide comprehensive technical solutions for complex issues related to quality processes, procedures, and systems to meet organizational objectives.
• Serve as a back up to Head of Quality in their absence.
Note: Essential functions may not be limited to the tasks and responsibilities listed within this section.
Do you qualify?
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• BS Engineering - Mechanical, Industrial/Manufacturing, Biomedical engineering, or science technical discipline
• 7+ years’ experience in engineering, science, technical and/or quality.
• 3+ years’ working knowledge of FDA medical device regulations and ISO 13485, FDA, and EU regulations.
• 3+ years’ working knowledge of Regulatory Standards
• 3+ years’ experience with Quality Management Systems (QMS)
• 3+ years’ experience with Root Cause Analysis Tools for CAPA planning
• 3+ years’ experience in internal audits, certified Lead Auditor preferred
• Strong understanding of medical device manufacturing processes and products
• 3+ years’ experience with general quality principles, procedures, and methodologies
• 3+ years’ execution of NCR and CAPA Processes
• 3+ years’ Writing and performing Installation, Operational and Process Validations
• Risk Management
Ability to travel when required – up to 10%
Position Type/Expected Hours of Work
This is a full-time position. Core hours of work are Monday through Friday, 8:00 a.m. to 5:00 p.m
The annual pay range for this position is $104,600 - $130,700.
The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.
This position is eligible for a Performance Bonus.
ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.
Your ZEISS Recruiting Team:
Christina ChoingZeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).
