Production Lead -Bipolar

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?  

SUMMARY Lead a department in a medical device manufacturing environment and ensure the highest level of production quality, efficiency, and output.

Sound Interesting?

Here’s what you’ll do:

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Comprehensive understanding of all applicable MSOP’s, QCSOP’s, GMP (Good Manufacturing Practices), and line clearance requirements.
• Audit employees and processes to ensure team members, product, and process meet specifications and standards.
• Assist the supervisor with employee coaching and providing timely performance feedback.
• Analyze the performance of production operators.
• Prepare and analyze production reports to present information at the daily morning production meeting.
• Prepare Production Reports for the designated manufacturing department(s).
• Maintain J.I.T. (Just In Time) and F.I.F.O. (First In First Out) methodology to optimize production operations.
• Analyze situations and utilize critical thinking skills to prevent or find resolution for production issues.
• Ensure the team, production department and processes are in line with company practices and safety standards.
• Utilize SAP to retrieve data used to run reports and key performance indicators for the assigned department.
• Communicate with the production supervisor and other production leads to coordinate production activities and share results.
• Works with cross-functional departments (planning, quality, engineering) to prevent or resolve production issues.
• Understand all primary processes in each manufacturing area for both: tumbling, cleanroom and packaging.
• Initiate and assist with processing Non-Conformance reports.
• Ensure working areas meet the 5’S (sort, set in order, shine, standardize, and sustain) methodology.
• Process Material Request Forms (MRF) to maintain inventory levels available to the production floor.
• Process Material Review Board reports when applicable.
• Receive and assign work orders and sterilized batches to production operators.
• Identify different lens and injector models and components.
• Identify and scrap defects per Zeiss quality standards.
• Review the work order BOM (Bill of Material) to gather the required material to perform assembly, inspection, and packaging operations.
• Perform SAP verifications and documentation review of work orders to ensure adherence to GDP (Good Documentation Practices).
• Able to use tweezers to handle product.
• Able to use a microscope and understand magnification levels for visual inspection.
• Perform SAP functions such as operation confirmations and label printing.
• Prepare product for sterilization by processing sub-lot confirmations, forms, reports and constructing batch configurations.
• Responsible for being the primary trainer of production operators and ensuring training effectiveness.
• Perform any other duties as performed.

Quality:

• Ensure that all finished product meets quality standards and specifications.
• Maintain a production environment that complies and follows all quality standards and government regulated standards.
• Performs manufacturing process according to MSOP’s & MPI’s.
• Performs in-process inspection according to QCSOP’s & QIS.

Do you qualify?

EDUCATION and/or EXPERIENCE

• High School diploma or equivalent.
• Three years of manufacturing experience in the medical device or similar industry.
• Experience with LEAN manufacturing principles.
• Proficient computer knowledge of SAP and Microsoft Office programs: Outlook, Excel, Word.

LANGUAGE SKILLS Ability to effectively communicate with others within and outside the organization (i.e. management, supervisors, coworkers, inspectors and auditors from various governing bodies, such as FDA auditors).

Work Environment:

The work environment characteristics d