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Quality Assurance Manager - Medical Devices - Torrance in Torrance, California at Phenomenex

Date Posted: 12/12/2018

Job Snapshot

Job Description

Job ID: PHE000545

About Us

Phenomenex is a global technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers in industrial, clinical, government and academic laboratories. From drug discovery and pharmaceutical development to food safety and environmental analysis, Phenomenex chromatography products, technical services and chemical reference standards accelerate science and help researchers improve global health and well-being. 

Selected by the Wall Street Journal as an "Exceptional Workplace," Phenomenex is defined by its passionate people, dynamic culture and distinctive ingenuity. These common characteristics unify the Phenomenex companies worldwide behind our mission "to promote the growth, prosperity and well-being of those we serve - our customers, our employees, and humanity.



Description

General Summary:

The Quality Assurance/Regulatory Affairs (QA/RA) Manager provides leadership, direction and hands-on involvement with the Phenomenex Quality Managements System in support of strategic directions and deployments objectives. Using prior industry knowledge of HPLC, cGMP, ISO 9001, and customer applications, the QA/RA Manager ensures products are developed, manufactured, inspected and tested to meet specifications, comply with QMS procedures and customer expectations.

Duties & Responsibilities:

1. Responsible for maintaining and improving the QMS and ISO 9001 Certification.

2. Schedules, plans reviews and analyzes internal quality system audits.

3. Ensures effectiveness of Corrective and Prevention Action (CAPA) Program

4. Drives the development and control of user friendly process documents.

5. Manages the document Control System (>7300 Documents)

6. Ensures QMS training is assigned and completed by all associates

7. Point of contact for customer and register on-site audits.

8. Ensures process and product Changes are documented and customer notification is performed.

9. Ensure nonconforming material is labelled, quarantined, documented and resolved.

10. Manages daily responses to customer surveys and requests for quality certificates

11. Coordinates and documents Supplier Quality Investigations and resolves associated issues

12. Follows all safety procedures, without exception

13. Provides Vacation Relief and other job-related functions as assigned


Job Requirements



Qualifications

Knowledge, Skills, & Experience:

• Bachelor’s Degree in Science or Business required. Master’s Degree preferred

• A minimum of seven (7) years of Operations, Engineering or QMS experience required

• Certified Lead Quality System Auditor or ASQ Certified Quality Auditor Required

• Experience with ISO 9001, ISO 13485 or cGMP required

• Experience with SPC, flow charting and problem-solving tools

• Must be able to drive projects to completion without compromising product quality

• Ability to effectively interface with associates, managers, customers and suppliers of various technical and management levels

• Effectively resolves conflict, works in teams, and meet deadlines is required

• Proficiency with Word, Excel, and PowerPoint required

• Excellent writing, verbal communication, and presentation skills are required


*LI-TH1.



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.