Supplier Process Engineer

Kindeva Drug Delivery; St. Louis (MO); On-site; USD 60,000 - 100,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401k Benefits

Paid Absences

Job summary

An established industry player is seeking a Supplier Process Engineer to oversee supplier-related activities and ensure compliance with medical device regulations. In this role, you will lead continuous improvement initiatives and manage projects within Supplier Process Engineering. Your expertise will be pivotal in coordinating supplier changes and ensuring that all processes meet validated parameters. This dynamic position offers the chance to make a significant impact on product quality and safety while working collaboratively with suppliers and internal teams. If you are passionate about engineering and quality assurance, this is an exciting opportunity to contribute to life-saving products.

Qualifications

• 2+ years experience in pharmaceutical or Quality Engineering.
• Knowledge of cGMPs and regulatory guidelines is essential.

Responsibilities

• Design and execute Supplier Process Engineering protocols.
• Coordinate Corrective and Preventive Actions for quality events.

Skills

Project Management

Continuous Improvement

Problem Solving

Quality Engineering

Education

BS in Engineering

Tools

cGMPs

FDA Guidelines

ISO Standards

ASTM Standards

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Supplier Process Engineer assists in the oversight, evaluation, and qualification of all supplier related activities, including outside processes and production. Additionally, this individual identifies and implements Continuous Improvement opportunities for the manufacture of supplied materials.

Role Responsibilities

• Designs, executes Supplier Process Engineering related protocols; and summarizes studies to ensure consistency of data production and compliance with MMT specifications, medical device regulations and current Good Manufacturing Practices.
• Responsible for coordinating and oversight of Corrective and Preventive Actions related to Quality events at the suppliers.
• Coordination and implementation of supplier change notifications, supplier process changes.
• Responsible for assisting in creating all applicable process documentation to guarantee production processing consistent within validated parameters.
• Capable of singular project management (within the realm of Supplier Process Engineering) for smaller scope Supplier Process Engineering Plans.
• Issues data, memos, presentations, and reports concerning Supplier Process Engineering projects or areas of interest.
• Evaluates equipment or process problems (at suppliers as needed) and executes testing to determine possible causes or solutions; assists in executing process capability studies of new equipment/tooling.
• Assists in ensuring product development activities have all necessary Supplier Process Engineering support.
• Interacts with outside testing laboratories and provides Supplier Process Engineering assistance where needed on specific issues.
• Coordinate with QCD lab execution of supplier related protocol execution.

Basic Qualifications

• BS in an Engineering related field
• 2+ years pharmaceutical, laboratory, manufacturing, or Quality Engineering related experience in a medical device/component field.
• Willingness to travel domestically and globally as needed (15-20% travel).

Preferred Qualifications

• Certified Quality Engineer, Six Sigma training and Lean Manufacturing training desired but not mandatory.
• Thorough knowledge of cGMPs. Good working knowledge of associated industry and regulatory guidance documents; FDA guidelines, ISO standards, ASTM standards, etc.
• Excellent knowledge/understanding of protocol acceptance criteria and capable of determining appropriate Corrective action/Preventative Action (CA/PA) for recommendation to management.

Compensation and Benefits

The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

Job Family B - Engineering - Supplier Process Engineering