Quality Engineer

About the role

The Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis, and corrective and preventive action for events. This role involves leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.

Additional responsibilities include:

• Assisting the Validation Engineer in the validation and certification of all new process equipment and periodically reviewing all certified systems to assure capability of meeting quality requirements.
• Implementing and maintaining the effectiveness of the Quality System.
• Supporting efforts to ensure all quality goals are met and all practices and procedures comply with company policies and applicable regulations.
• Ensuring investigations of plant events are completed thoroughly, documented accurately, and included in the plant CAPA system.
• Performing product impact analyses for plant events and placing product on QA hold where appropriate.
• Maintaining an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Participating on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approving standard operating procedures and ensuring they comply with policy and are practical.
• Approving calibration requests and ensuring these requests have appropriate product/process limits assigned.
• Developing and implementing statistical quality programs, and ensuring all acceptance sampling meets expected product quality confidence levels for manufactured as well as purchased materials.

Requirements

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

Skills

• Quality System and Regulatory Knowledge: Strong knowledge of ISO 13485, ISO 14971, and FDA 21 CFR part 820/QSR.
• Risk management and FMEA understanding.
• Technical problem-solving and root cause analysis expertise.
• Communication and cross-functional influence.
• Manufacturing Quality Experience and process knowledge.

Schedule

Monday–Friday, 8 AM–5 PM; rotating weekly on-call shifts for evenings and weekends.

Benefits

• Healthcare Insurance: Eligible employees and their dependents receive healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics. Premiums are subsidized by Synectics.
• Dental Insurance: Eligible employees and their dependents receive a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.
• Vision Insurance: Eligible employees receive vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.
• 401(k) Plan: Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.