Flexan is a global strategic contract manufacturer of custom high-quality silicone and thermoplastic components, sub-assemblies and devices designed to meet the critical requirements of Class I, Class II and Class III medical devices, as well as custom compounding and molding for precision parts.

The Sr. Quality Manager is responsible for managing and implementing the Quality Management System and processes across the site. This position oversees quality assurance and compliance functions and ensures integration throughout departments to ensure the Quality Management System (QMS) is compliant to standards and products meet quality specifications.

KEY ROLE AND RESPONSIBILITIES

• Responsible for developing, maintaining and executing on quality procedures to inspect and report quality issues

• Oversees maintenance of the requirements and monitors the effectiveness of the ISO quality system as well as continually proposing improvements to the system

• Oversees the management of the QMS to ensure compliance with relevant regulatory bodies.

• Accomplishes quality assurance human resource objectives by recruiting, selecting, orienting, training, scheduling, coaching, counseling, and disciplining employees; communicates job expectations and leads team in talent and performance management processes

• Responsible for understanding customer needs and requirements to develop effective quality control processes

• Hosts customer and regulatory audits, as well as coordinates and performs internal quality and supplier audits as needed

• Leads all internal and external CAPAs, Non-Conforming Reports, and customer complaints including investigation, root cause analysis, and other related documentation.

• Ensures all document control and revision control activities are carried out to ensure compliance

• Ensures all products conform to validated processes and Device Master Records, as well as performs lot release and related functions

• Assures the reliability and consistency of production by checking processes and final output

• Provides oversight of calibration and preventive maintenance program to ensure compliance

• Collaborates with purchasing department and co-manages the approved supplier list and evaluates them to ensure product compliance

• Monitors approved supplier list and rates suppliers through score card ratings

• Ensures all SOP’s and process documentation are created in accordance with the QMS and works with all departments to ensure effectiveness

• Provide resources, support, ideas and recommendations to facilitate growth of a “culture of quality”

• Updates job knowledge by studying trends in and developments in quality management, participating in educational opportunities, reads professional publications and participates in professional organizations and networking opportunities

• Communicate effectively with Flexan LLC’s management. Must have excellent written and verbal communication skills and be able to present quality data to their customers and senior leadership in a concise, effective manner.

• Demonstrates all the Flexan corporate values:

• We have an engaging culture.

• We embrace the rigor to be safety and quality driven in all that we do.

• We embrace our choice to work here.

• We operate with transparency, ethics, and integrity.

• We consistently meet our expectations.

• We encourage innovation.

  MINIMUM QUALIFICATIONS:

• Bachelor’s degree in quality, mechanical or industrial engineering preferred, or equivalent experience

• 7 years + years of professional experienced in quality leadership with progressive scope and responsibility; med device/products experience preferable.

• Experience in leading the Quality Organization in a manufacturing environment, med devices preferable and cleanroom environment experience preferable.

• ISO 13485, FDA 21CFR820, and Good Manufacturing Practices; Certified ISO 13485 Auditor or similar certificate a plus; experience with hosting notified body and FDA audits a plus.

• Familiarity with Quality Agreements, PPAP, APGP, and MSA

  It is the policy of Flexan, LLC to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Flexan will provide reasonable accommodations for qualified individuals with disabilities. 

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