Quality and Compliance Manager

Carl Zeiss GmbH; New Britain (CT); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical – 90% employer paid

Dental – 100% employer paid

Life Insurance, AD&D, STD & LTD – 100%

Vision

401k Matching

Paid Sick, Vacation, Holidays

Job summary

ZEISS in New Britain, PA, seeks a Quality Engineer to ensure manufacturing quality aligns with regulatory standards. The role collaborates with Manufacturing Engineering, supports process validation, risk management, inspections, and CAPAs, and may travel up to 25% to New Britain and Exeter/Seabrook locations.

Qualified candidates will have a minimum 5 years in QA for medical devices or pharma, a bachelor’s degree in engineering, and experience with FDA inspections and document control.

Qualifications

• Experience applying quality systems in medical devices or pharma.
• Ability to translate quality requirements into actionable guidance.
• Proven track record with FDA inspections and regulatory audits.
• Strong documentation and CAPA management skills.

Responsibilities

• Identify and support process validation activities.
• Assist with plant layout/process projects for efficiency and timeliness.
• Lead or support PFMEA and risk management activities.
• Oversee design transfers to manufacturing and QA release activities.
• Inspect labeling and documentation for finished goods release.
• Ensure procedures are followed and changes are properly validated.

Skills

Quality engineering

FDA inspections

CAPA investigations

PFMEA

Documentation control

Cross-functional collaboration

English communication

Education

Bachelor's degree in engineering

Job description

About ZEISS

About Us: How many companies can say they have been in business for over 178 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the ever-changing environments in a fast-paced world, meeting it with cutting edge 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 Quality Engineer serves as a key quality assurance resource, providing hands-on support to ensure ongoing product manufacturing aligns with established quality and regulatory standards. This position works very closely with the Manufacturing Engineering team, is directly involved in day-to-day production processes, and can act as a backup for all quality-related responsibilities.

Key Responsibilities

• Identify and assist with process validation activities.
• Support projects related to manufacturing plant layout/process to ensure efficient and timely completion.
• Manage multiple projects in various stages of production, including, process improvements, quality inspections, and quarantine and inventory control.
• Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA).
• Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
• Inspect product including labeling and documentation for release of finished goods.
• Assist with Operations and Engineering to ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs.
• Ensure that changes to procedures are reviewed, approved and validated prior to implementation.
• Oversee creation and review of documentation for nonconforming products.
• Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs.
• Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewed.
• Keep management informed of significant issues identified during production‑related quality activities as well as actions being taken to improve and correct the situation.
• Assist with revisions and updates to quality procedures, standardized work instructions.
• Participate in supplier management activities.
• Identify supplier quality issues and report to management in timely manner.
• Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.).

Qualifications

• Solid understanding of quality system requirements set by the major regulatory frameworks for medical devices and combination products.
• Relevant experience in managing and overseeing quality aspects in distribution, preferably in disposable devices as well as pharmaceutical products.
• Ability to effectively translate quality requirements into practical directions for the organization.
• Experience in management of FDA and/or Notified Body inspections.
• High level of integrity and ethical standards.
• Ability to multi-task and methodically manage projects based on business priorities and resource availability.
• Ability to self-motivate and work independently in a geographically separated multi-national and multi-functional team environment.
• Collaborates effectively across a diverse network.
• Open-minded for improvement opportunities and change towards striving for best-in-class compliance performance.
• Ability to think creatively, proactively identifying alternative solutions to problems.
• Experience in people management.
• Effective communication/interpersonal skills.
• Fluent in English (written and spoken).
• The role requires up to 25% travel to New Britain, PA, with the remaining time divided between the Exeter & Seabrook, NH locations.
• Advanced level in Microsoft Office suite applications.
• Minimum Bachelor degree in a relevant field of engineering.
• Qualification in Quality Assurance (e.g. six-sigma, lean, ASQ).
• Minimum 5 years in a senior role in Quality Assurance in medical device or pharma industry.

Benefits

• Medical – 90% employer paid
• Dental – 100% employer paid
• Life Insurance, AD&D, STD & LTD Insurance – 100% employer paid
• Vision
• 401k Matching
• Paid Leave: Sick, Vacation and Holidays
• The list goes on!

Work Location & Travel

This is a full-time, fully onsite opportunity. This requires up to 25% travel to Exeter & Seabrook, NH locations, with the remaining time in New Britain, PA. The role requires up to 25% travel to New Britain, PA, with the remaining time divided between the Exeter & Seabrook, NH locations.

Company Culture and Diversity

Zeiss 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).

Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

Your ZEISS Recruiting Team: Jo Anne Mittelman