Engineer -QA Staff
Title: Staff QA Engineer
ReportsTo: Manager– Quality Engineering
Communicates directly with Quality, Regulatory Affairs, R&D, Manufacturing, Operations, and Supply chain and other applicable teams to support in Quality System improvement and compliance.
Responsible for assuring quality standards and regulatory compliance are consistent with Corporate and Plant Policies, Government Regulations, supporting the continued development, improvement, and implementation of the Quality Systems within kdc/one. Identify and assess quality risks in activities and processes according to regulatory agency rules and guidelines and the company quality practices.
- Maintains and improves the kdc/one Quality System for assigned elements.
- Collaborates with cross functional partners to seek their input into the development of policies and procedures, Quality System manuals, and their support in addressing Quality Issues. Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Plant, Regulatory Requirements, etc.
- Facilitates cross-functional interaction and communication between Quality, Regulatory Affairs, R&D, Manufacturing, Operations, and Supply chain and other applicable teams to support in Quality System improvement and compliance.
- Participates and supports internal and external regulatory site visits, inspections, and audits. Including ensuring that pre- and post-inspection activities are completed including scheduling, record review, training, logistics, etc.
- Assists with FDA, NB, Corporate, Customers and other regulatory, external, and internal audit readiness and processes harmonization globally.
- Partner with supply chain to ensure vendor quality is executed for all vendors shipping product to facility.
- Applies quality and/or standard-setting body requirements to develop solutions, control and/or maintain technical documents and/or Quality Systems.
- Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
- Determine the logic, adequacy and effectiveness of processes, systems, and related requirements.
- Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
- Maintain the Revision of Procedures plan up to date
- Trains, develops, and provides technical guidance to other associates.
- Actively participate in quality guidance and helps project & quality network teams for process improvement, standardization initiatives, and continuous improvement activities
- Drive Monthly reviews of KPI’s and contribute towards meeting the yearly business Goals for the Facility
- Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s).
- Completes projects/other duties as assigned.
·Knowledge of US and International regulations and standards that apply to the OTC and Cosmetic industry including FDA Quality Systems Regulations, ISO 22716 & 9001.
·Consistent understanding of the application of quality systems to the Cosmetic and OTC industries.
·Industry recognized certification in a Quality System element specialty (e.g. ASQ Certified Quality Auditor, Quality Engineer) preferred.
·Experience with Quality Management Systems, 5+ years.
·Experience in working directly with Notified Bodies, customers and Regulatory Authorities preferred.
·Prior experience managing and scheduling internal and external audits.
·Excellent communication skills at all levels both written and verbal.
·Ability to set and deliver to specific goals and targets.
·Ability to perform multiple tasks and prioritize workload.
·Effective analytical, technical, and problem-solving skills.
·Effective meeting and presentation skills.
·Effectively manage conflict.
·Ability to work in or direct teams to obtain results.
- – challenging the team, organized, enthusiastic, attention to detail, conscientious.Performance
- – Decisions are based on seeing and being part of the event, not solely based on report reading. Know and understand the role.Hands on approach
- – Able to work under pressure, meet deadlines whilst delivers right first-time quality.Zero compromise on Quality and excellence
- – Always strives to be creative, wants to present the best products possible from a maintained, clean, and safe factory environment.Entrepreneurial
- Logical, creative, and committed. Able to problem solve.Continually striving knowledge of the process and product -
- – commit and coordinate the Quality team in order to achieve better outcomes.Teamwork
- – monitor and guarantee the respect of the quality standards and GMP in order to avoid complaints and consumer safety issues.Accountability
- – prepare the standard according to the consumer expectation, guarantee the implementation of the standard in order to ensure consumer satisfaction.Consumer focused
KDC-ONE is an equal opportunity employer and does not discriminate on the basis of race, religion, color, national origin, age, sex, gender, disability or any other characteristic protected by law. I understand that employment with KDC-ONE Company is at-will, meaning that I or KDC-ONE Company may terminate my employment at any time, or for any reason consistent with applicable state or federal law. I understand that KDC-One requires the successful completion of a drug and/or alcohol test as a condition of employment.
- Pay Type Salary
- Employment Indicator Indirect
- kdc/one Port Jervis, 20 West King Street, Port Jervis, New York, United States of America