Job Title: Senior Quality Engineer
Location: Buffalo Grove IL (Onsite)
Job Description & Skill Requirement:
- A Senior Quality Assurance Engineer assures products processes and quality records conform to quality standards and establishes compliance with the quality system.
- Responsible for maintaining a strong collaborative partnership with cross-functional team members.
- Lead on-time completion of Quality Assurance (QA) engineering deliverables.
- Accountable for leadership decision making and oversight of the quality systems including CAPA (Corrective and Preventive Action) systems.
- Works with and influences key stakeholders to develop and maintain QA procedures forms and systems.
- Develop and lead training for QA systems.
- Influence and guide other team members with product review and analysis for QA activities.
- Maintain databases and record storage for QA systems.
- Process QA requests ensuring owners are assigned and timely responses are provided in alignment with quality goals.
- Lead meetings and communications for QA system information concerns and updates.
- Lead and mentor others with QA data analysis trending and reporting.
- High proficiency with reporting and publishing weekly monthly and quarterly metrics.
- Track and proactively identify concerns manufacturing related complaints in alignment with SJM goals.
- Plan and prevent potential system issues.
- Lead Global CAPA team with training CAPA oversight and CAPA deliverables. Proficient as lead representative for presenting QA System to internal and external auditors.
- Investigate and resolve system nonconformances and concerns (defined during internal and external audits).
- As appropriate it leads in the completion of risk assessment as related to QA systems.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) Environmental Management Systems (EMS) and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.
- Performs other related duties and responsibilities on occasion as assigned.