Senior Quality Engineer (Pharma Division) - ProMed Molded Products, Inc.

Responsibilities Include:

Being a key contributor and valued team member of ProMed Pharma and assist in our strategic plan to grow our Pharma customer base, be recognized worldwide by our customers and the regulatory agencies as having a top tier quality system from R&D through final production. Responsible for overall compliance, process and quality assurance activities on numerous projects and products including pharmaceutical, medical device, and combination products. Develop and teach systems that assure a complete and auditable quality focus at every step of the process.

Essential Functions of Job:

• Ensures the Quality Management System activities are developed and deployed in an efficient and effective manner that supports the company's quality objectives.

• Directly responsible or oversees approval, and rejection of procedures and specifications impacting products.

• Directly responsible or oversees investigations of process issues (CAPA, process deviations, non-conforming product, and customer complaints).

• Be a key team member on process development teams by ensuring that decisions of the team are risk based and data based to a known level of confidence.

• Point out technical and compliance requirements, perform gap assessments, and resolve technical issues throughout the product life cycle.

• Help with regulatory, customer, and supplier audits.

• Perform and document root cause investigations, present findings, and propose possible corrective actions for non-conformances.

• Perform statistical analysis of data for problem solving and process development purposes.

• Work with R&D and Production engineers to identify and/or resolve issues.

Education/Experience:

• Degree in science or engineering, that would be relevant to medical device or pharmaceutical manufacturing.

• A minimum of eight years of experience related to quality or manufacturing excellence in a technology driven field.

• Understanding or experience in Lean and Six Sigma methodologies.

• Working knowledge of Microsoft Excel, Word, Minitab or other software for statistical analysis.

• Possess good communication and problem-solving skills.

• Familiarity with DMAIC problem solving process.

• Good statistical analysis capability and working knowledge of Design of Experiments and related software tools.

• Knowledge of the use of risk management tools for development and problem solving purposes.

• Experience with statistical sampling

• Experience with working in a regulated industry.

• Team player in a dynamic and ever-changing environment.