Quality Engineer- ISO 13485​/ISO 14971​/ 21 CFR

Quality Engineer II

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, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and policy compliance for the manufacturing plant.

Responsibilities:

• Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements.
• Responsible for implementing and maintaining the effectiveness of the Quality System. Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations.
• 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.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; ensures procedures comply with policy and make sense.
• Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
• Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.

Qualifications:

• 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 / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Top 3 – 5 Skills Needed for each role:

• Quality System and Regulatory Knowledge - Strong knowledge of ISO 13485, ISO 14971 and FDA 21 CFR part 820/QSMR
• Risk management and FMEA understanding
• Technical problem Solving and Root cause analysis expertise
• Communication and Cross-Functional Influence
• Manufacturing Quality Experience and process knowledge

Pay Rate- 40 to 45

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.