What You'll Work On
- Participate in the selection, training, scheduling, and evaluation of a team of in-process (IPQC) or incoming quality control (IQC) inspectors.
- Maintain company quality standards
- Oversee the product manufacturing process to ensure quality
- Coordinate training activities to ensure compliance with regulatory requirements and ensure cross-training and flexibility across the Quality Inspection group
- Provide ongoing feedback and mentoring of Quality Inspectors, including writing and delivery of annual performance evaluations.
- Determine training and professional growth plans for Quality Inspectors.
- Support investigations associated with non-conformances.
- Work with engineers to determine appropriate support activities for non-conforming goods and new products.
- Interface with the FDA, state agencies, and notified bodies during certification, surveillance and routine ISO audits.
- Participate in cross-functional Quality Objective teams.
What You Bring
- A desire to work and learn in a dynamic, fast-paced environment.
- A Bachelor’s degree and three to five years of supervisory experience in Quality Assurance, Quality Control, biotechnology, document control, or a related field, or an equivalent combination of education and experience.
- A passion for leading teams, solving problems, and thinking critically.
- Outstanding verbal, written and interpersonal communication skills.
- Proficiency with Word, Excel, Access, and Power Point strongly preferred.
- Highly desired is an understanding of FDA QSRs, ISO standards, and the MDD. ASQ certifications for CQIA, CQA, or equivalent.
What We Offer
- A collaborative teamwork environment where learning is constant and performance is rewarded.
- The opportunity to work cross-functionally with engineering, manufacturing, and other departments.
- The satisfaction of being at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
- A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
PENUMBRA TODAY Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on interventional therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Want to learn more about Penumbra? Visit Penumbra's website.
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