QA Engineer

PRIMARY FUNCTION / POSITION OVERVIEW:

* Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policies.

* Develops and maintains schedules and timelines.

* Ensures the documentation process remains compliant.

* The role provides guidance for the various elements of the Quality System to ensure process control, consistent supplier qualification practices, and identifies/recommends opportunities for continuous improvement.

* Appropriate statistical tools to analyze data, identify root cause, and determine corrective actions for effective problem resolution.

* Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products.

* Assesses Critical to Quality (CTQ) parameters and risk assessment variables as part of the decision-making processes to support predictable product design and flow

* Initiates CAPAs and may lead the investigation/corrective action process.

* Responsible for day-to-day Quality Engineering responsibilities for product and related operational areas

* Responsible for assuring departmental compliance with ISO and other requirements through supporting plant trainings and initiatives.

* This specific role will have a focus on site validations of equipment, software, and materials.

* Develops, documents, administers, and maintains Quality Systems for conformance, regulatory requirements, and company policies.

* Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments.

* Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans, and design control.

* Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes, and verifies effectiveness of changes.

* Supports internal and external audits and assists in administering the audit program.

* Develops and maintains efficient methods for regularly reporting to management the status of product quality with respect to Quality objectives and goals and provides plant quality metrics as required to generate quality system improvements.

* Facilitates investigation of customer complaints

* Initiates preventive action plans in response to valid customer complaints.

* Defines Change Control requirements for the plant related to manufacturing, facility, and material changes.

* May provide full support to raw material changes assuring that all Quality Systems and requirements are met.

Qualifications/Skills:

* Leadership

* Strong written and verbal communication skills

* Strong Conflict Resolution Skills

* Collaboration skills

* Computer knowledge and skills

MINIMUM EDUCATION LEVEL:

BA or BS in appropriate discipline (preferred but not required)

Minimum of 5 years relevant experience

FUNCTIONAL/TECHNICAL EXPERTISE:

Knowledge of safety requirements and legal standards

Working knowledge of quality system requirements

Experience with Microsoft Office, Power BI, SAP (preferred but not required)

• Fully vested 401k match, up to 7% of total eligible compensation.
• Competitive Medical, Dental and Vision Plans - Effective from first day of hire.
• 3 weeks' vacation which increases with tenure, 7 sick days, 3 floating holidays and8 Company Observed Holidays.
• Tuition Reimbursement - Eligible after 6 months of service.
• Parental Leave - 100% base pay for 6 consecutive weeks within first year of achild's birth or adoption.
• A wide range of development opportunities to boost your professional and leadership growth.