Planet Pharma ยท 2 hours ago
Supplier Qual Engineer II
Boulder, CO
Full-time
Onsite
Entry Level
2+ years expPlanet Pharma is focused on maintaining high standards in quality and compliance, and they are seeking a Supplier Qual Engineer II to play a key role in this mission. The role involves qualifying new suppliers, leading audits, and ensuring compliance with GMP and regulatory standards to influence product reliability and patient safety.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Drive and manage supplier quality activities related to projects (approved supplier list updates, PPAPs, and general project support). Ensure that suppliers deliver quality parts, materials, and services
Qualify suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness
Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems as they occur
Develop and prioritize an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met
Evaluate suppliers' internal functions to assess their overall performance and provide feedback in assessment of their operation
Collaborate with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products
Define Receiving Inspection requirements as required and associated test method validation for all internal company Test Methods
Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow the company to provide customers with the highest quality and reliable products
Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements. Ensure that suppliers deliver quality parts, materials, and services
Qualification
Required
Experience with supplier audits, qualification processes, and maintaining Approved Supplier Lists to ensure compliance with GMP and regulatory standards
Strong understanding of quality management systems, regulatory requirements, and compliance project support within a manufacturing or medical device environment
Proficiency in identifying, investigating, and resolving supplier-related issues using structured problem-solving methodologies
Requires a university/ bachelor's degree (preferable in engineering, technology, or science)
2 years minimum experience
Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience
Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years relevant experience
Preferred
Strong written and verbal communication skills
Solid presentation and computer skills (Excel/Word/PowerPoint/Projects, etc.)
Project management skills
Self-starter, self-motivated attitude with the ability to multitask and thrive in a fast-paced environment
Excellent interpersonal communication skills
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase