Manufacturing Site Quality Assurance Lead - Portage

The Manufacturing Site Quality Assurance Lead ensures product quality, safety, and compliance at the site level by managing QA systems, audits, and quality controls (QC). Leading a team of QA professionals, this role safeguards products, systems, and materials against defects while aligning with company, customer, and international standards. Key responsibilities include establishing quality assurance policies, conducting audits, ensuring rapid response for quality issues, and driving defect prevention through process controls, root cause investigations, and corrective actions. By embedding accountability and fostering cross-functional collaboration, the leader ensures consistent product quality, regulatory compliance, and sustainable operational excellence.

Primary Responsibilities:

Quality Management System

Contribute to the identification and evaluation of current policies and business processes that are in the scope of the quality management system (QMS); contribute to the design of the QMS; provide specialist quality management input to the drafting of new policies and procedures and the design of business processes; contribute to the quantification of the costs and business benefits of change.

Health, Safety, and Environment

Follow the organization's health, safety, and environment (HSE) policies, procedures, and mandatory instructions to identify and mitigate environmental risks and risks to the well-being of self and others in the workplace. Identify patterns of risky behavior within the team and take appropriate action to resolve them, escalating serious issues as appropriate.

Quality Assurance Testing Design

Validate new or existing complex test methods and procedures; identify issues and recommend improvements to contribute to further development.

Leadership And Direction

Communicate the local action plan; explain how this relates to the function's strategy and action plan and to the broader organization's mission and vision; motivate people to achieve local business goals.

Quality Assurance Testing

Select the appropriate complex tests or tests from a specified range and carry out using specialized methods and equipment; validate and interpret test data to verify that specifications are met and/or to identify remedial actions required to ensure conformance or suitability.

Improvement / Innovation

Identify shortcomings and suggest improvements to existing processes, systems, and procedures, then deliver a plan for a small element of a change management program with guidance from a project/program manager.

Operational Compliance

Identify, within the team, instances of noncompliance with the organization's policies and procedures and/or relevant regulatory codes and codes of conduct, reporting these instances and escalating issues as appropriate.

Data Collection and Analysis

Collate and analyze data using preset tools, methods, and formats. Involves working independently.

Problem Solving Journey

Lead problem-solving and rapid response to quality control activities, ensuring flawless quality. Develop mechanisms to prevent issues through the application of sophisticated quality assurance activities and controls.

Stakeholder Engagement

Assist with stakeholder engagement by arranging actions, meetings, events, and supporting materials to promote stakeholder understanding and commitment.

Performance Management

Respond to personal objectives and use performance management systems to improve personal performance; or monitor the performance of the team, allocate work and review completion, take appropriate corrective action to ensure timeliness and quality, and contribute to formal individual performance management and appraisal.

Organizational Capability Building

Provide coaching to team members to develop their skills.

Budgeting

Track budgets and report variances to more senior colleagues.

Tasks

• Develop and maintain manufacturing Quality Control (QC) plans - Define inspection points, sampling methods, and testing requirements across production processes. 
• Oversee execution of product and process inspections - Ensure QC checks are performed as defined and results are accurately recorded. 
• Manage and improve the site Quality Management System (QMS) - Maintain QA policies, procedures, and documentation to meet standards like ISO 9001 and customer requirements. 
• Lead internal quality assurance audits for manufacturing processes - regularly audit production lines to identify gaps and ensure compliance with quality. 
• Review and analyze QC data to identify trends and risks - Use inspection and testing data to detect patterns and prevent defects. 
• Lead the plant quick response for quality controls. Lead the root cause analysis and corrective/preventive actions. Ensure the application of the correct quality tools and structured problem-solving for manufacturing nonconformities and drive resolution. 
• Ensure verification and calibration of inspection, measuring, and test equipment - Oversee programs to ensure all tools used in QC provide reliable result. 
• Monitor process changes impacting product quality - Provide QA oversight for engineering or process adjustments, ensuring quality is not compromised. 
• Support the introduction and validation of new manufacturing processes and new product introductions (NPI) - Ensure quality controls are in place before new processes or products go live. 
• Communicate QC/QA results and drive actions with manufacturing teams - Share quality performance, engage cross-functional teams, and ensure actions are followed through. 
• Ensure adoption of lessons learned and best practices. Engage and support continuous improvement activities. 

Education

Bachelor's Degree or Equivalent Level; Engineering degree preferred.

Experience

Experience enables job holder to deal with the majority of situations and to advise others (Over 3 years to 6 years in quality leadership capacity); Six sigma black-belt preferred .

Experience of supervising and directing people and other resources to achieve specific end results within limited timeframes (13 months to 3 years)

Closing

The above statements are intended to describe the general nature and level of the work being performed by employees assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. MonoSol, LLC reserves the right to make changes to the job description whenever necessary.

Disclaimer

As part of MonoSol, LLC’s employment process, finalist candidates will be required to complete a physical, drug/alcohol test and background check prior to employment commencing. MonoSol, LLC is an equal opportunity employer. All qualified applicants will be considered without regard to race, national origin, gender, age, disability, sexual orientation, veteran status, or marital status.