Quality Engineer 3

Fusion Life Sciences; Branchburg Township (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Fusion Life Sciences is seeking a Senior Quality Engineer to lead manufacturing QA efforts in a 12+ month onsite role in Branchburg, NJ. The position focuses on maintaining quality systems, regulatory compliance, risk management, and troubleshooting across production and automation projects.

The Senior Quality Engineer will support deviation investigations, validation activities, CAPA, and data integrity while coordinating with operations and QA teams to ensure product quality and regulatory

Qualifications

• Quality system knowledge including ISO 13485, ISO 14971 and FDA 21 CFR part 820/QSMR.
• Experience with risk management and FMEA.
• Strong problem-solving and root-cause analysis skills.
• Excellent written and verbal communication; cross-functional influence.
• Experience in manufacturing quality across API, Bulk Drug or finished goods.

Responsibilities

• Maintain and improve the Quality System and regulatory compliance.
• Provide QA support for projects related to production, systems, products and automation.
• Lead risk management activities and CAPA processes.
• Oversee data integrity and system security across manufacturing info systems.
• Collaborate with operations and other QA functions to resolve deviations and investigations.

Skills

Quality system

Regulatory knowledge

Risk management

Technical problem solving

Communication

Education

Bachelor's degree in Biology, Chemistry or Engineering

Job description

Title : Quality Engineer 3

Location: Branchburg, NJ
Duration : 12+ Months

100% Onsite

M-F 8 am - 5 pm; Rotating weekly on-call shifts for evenings and weekends

2 rounds of interviews 1st on Video and 2nd if selected to move on will be onsite.

Top 3 5 Skills Needed for each role

1. Quality System and Regulatory Knowledge - Strong knowledge of ISO 13485, !SO 14971 and FDA 21 CFR part 820/QSMR

2. Risk management and FMEA understanding

3. Technical problem Solving and Root cause analysis expertise

4. Communication and Cross-Functional Influence

5. Manufacturing Quality Experience and process knowledge

Job Description Senior Quality Engineer

The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant. The Senior Quality Engineer will provide Quality support for projects related to core production, new software/computer systems, new products/technologies/Automation systems. As part of the project team, the Senior Quality Engineer will ensure all activities including Qualification/Validation Strategy, Deviation Investigation and Resolution, Risk Management activities, etc. meet applicable Quality and Regulatory requirements.

Additionally, the Senior Quality Engineer supports on-going production including by working with operations/quality teams for deviation resolution, auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support the site to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Provide Quality support on project work related to Equipment installation/Computer Systems/Automation Systems while ensuring compliance with applicable regulations/standards. Lead project activities related to Quality and Compliance. Support Core production/ process improvement projects as assigned.
• Oversee data integrity initiatives to ensure security, accuracy, consistency, and completeness of data throughout system usage.
• Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc. Update risk management file documents as needed.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments including remote off-shift support as required.
• Approves standard operating procedures; ensures procedures comply with policies and regulations.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering
• 6+ years of overall experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills.
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Preferred

• Experience in manufacturing within pharmaceutical, medical device, biotechnology and food industry with cGMP is highly desirable
• Experience with implementing and maintaining the effectiveness of the Quality System.