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Supplier Qual Engineer II
5920 Longbow Drive Boulder, CO 80301 US
Job Description
Play a key role in the company's quality and compliance by maintaining and updating the Approved Supplier List, supporting supplier-related compliance projects, and ensuring our suppliers meet rigorous quality standards. You’ll qualify new suppliers, lead audits to uphold GMP and regulatory requirements, and work closely with engineering teams to resolve issues and implement effective quality strategies for new products. This position offers the opportunity to directly influence product reliability, patient safety, and continuous improvement across the company's supply chain.
Top 3 technical skills that are required for the role:
- 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.
Education Required:
Requires a university/ bachelor’s degree (preferable in engineering, technology, or science)
Years’ Experience Required:
2 years minimum
Responsiblities may include the following and other duties may be assigned:
- 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.
- 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.
Nice to Have
- 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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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