Supplier Quality Engineer

Heron Therapeutics develops cutting-edge medicine to meet unmet patient needs and solve big problems by applying our innovative science and technologies with well-known pharmacology. With therapeutic areas in Oncology and Acute Care, our goal is to offer alternatives so patients can be opioid-free post-surgery. With additional products and indications on their way, we are excited to be growing and adding to our amazing team.

The Supplier Quality Engineer is focused on managing the evaluation and monitoring of contracted service suppliers to ensure products and services conform to Heron quality standard expectations. This position is responsible for ensuring compliance to Quality System Regulations, Quality policies, Quality Objectives, GMP/GCP/GLP/GVP, FDA, ISO and other regulations pertinent to Heron products as well as product quality and compliance objectives.

This is a temporary/contract position that can be done remotely.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Manage end to end performance of all GxP suppliers, including but not limited to: Quality Agreements, Auditing, Audit schedules, Approved Supplier List, Master Supplier Files, Supplier Qualification, Supplier Corrective Action Requests (SCAR), etc.
• Oversee the supplier audit program, as lead auditor or coordinator for audits, and work to mitigate major/critical findings.
• Managing performance of suppliers via best practices such as Scorecards to drive continuous improvement
• Support the supplier selection and qualification process
• Work with suppliers to establish control methods suitable to the nature of the product they supply.
• Build relationships with suppliers to ensure all levels of manufacturing understand the product requirements.
• Responsible for reporting of quality trends and information to management on the performance of supplier.
• Work with supplier to establish a structured approach for consistency and adherence to quality procedures and requirements.
• Other duties as assigned.

REQUIREMENTS:

• Bachelor of Science degree in Science, Technology, Engineering, or Math (STEM), preferred and at least 3 years’ experience with Supplier Quality in a manufacturing environment strongly preferred.
• Experienced working with Contract Manufacturers
• Certified ISO 13485 Lead Auditor, preferred
• Direct experience with Pharmaceuticals, APIs, and/or Medical Device industry, in a regulatory environment preferred
• Must have good communication skills.
• Candidate must be able to work autonomously and independently.
• Ability to influence others and build effective working relationships both internally and externally at various organizational levels

The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.