Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Job Summary

The Senior Quality Compliance Specialist partners with cross-functional stakeholders to ensure the effectiveness of the Quality Management Systems (QMS). This position ensures and mantains the compliance quality system processes including Supplier Quality Management, Quality Events Management, Corrective Action and Prevention Action (CAPA) Management, Good Manufacturing Practice (GMP)/QMS Training. Collaborates with other internal teams to respond to change orders and document management system requirements. Works closely with company management and employees to carry out responsibilities in compliance with established procedures. Completes all work in accordance with Inova Quality Management Systems.

Key Accountabilities

• Teamwork: Collaborates with cross-functional stakeholders to ensure compliance of the Quality Management System to applicable regulations and standards. Provides education, guidance and direction on QMS compliance processes.
• Quality Management Systems: Develops, collects, trends, analyzes, reviews, and publishes quality metrics. Leads and/or represents Quality Assurance in cross functional teams. Designs and documents quality systems revisions. Creates and implements processes modifications. Ensures departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards. Ensures QMS processes, procedures, and quality documentation are consistently in a state of audit readiness. Addresses and resolves minor events and escalates major events that may contribute negatively to QMS processes or effectiveness. Administers compliance quality systems. Improves the systems within the Quality function as metric indicate. Supports other functions in resolving quality systems issues and concerns.
• Quality Events: Processes Quality Events. Monitors and administers Quality Event activities to ensure they are performed per commitments and closed per due date. Prepares agendas and presentations, coordinates meeting logistics, and generates or reviews minutes for review boards, e.g., MRB, Quality Review Board (QRB).
• GMP and QMS Training: Provides GMP and QMS Creates and maintains content, delivers training, and ensures training effectiveness, including but not limited to annual and new-hire GMP and QMS training. Administers the annual and new hire GMP and QMS training.
• CAPA Management: Monitors and administrates CAPA activities to ensure they are performed per commitments and closed per due date. Prepares agendas and presentations, coordinates meeting logistics, and generates or reviews minutes for the QRB.
• Product and Process Change Management: Monitors and administers Product and Process Changes activities to ensure they are performed per commitments and closed per due date. Prepares agendas and presentations, coordinates meeting logistics, and generates or reviews minutes for the Product Change Record Review Board (PRC).
• Supplier Management: Administers Supplier Quality Management activities such as supplier qualification, Approved Supplier List maintenance, supplier files maintenance, supplier surveys renewal, quality agreements renewal. Creates Quality Agreements and administrates supplier impact assessment process. Prepares agendas and presentations, coordinates meeting logistics and generates minutes for Supplier Review Board (SRB).
• Management Review: Coordinates the collection of information and pre-reviews for suitability and completeness in support of Management Review. Generates/reviews minutes and archives records from Management Review.
• Audit: Coordinates audit logistics. Manages back-room activities during internal and third-party audits and regulatory inspection preparation. Serves as subject matter expert (SME) for compliance quality systems. Administers the closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions.
• Complies with applicable SOPs, ISO, FDA, and other applicable Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources, and all other policies.
• Reflects Werfen Values in both quality of work and in working relationships.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• Manufacturing and Operations teams
• R&D teams including Manufacturing Technical Support
• Contract manufacturers and Suppliers
• Marketing
• Regulatory
• Quality Teams (Quality Assurance, Engineering, Product Support, Post Market Compliance, Document Control)

Minimum Knowledge & Experience

Education

• Bachelor's degree in a life science, engineering, or equivalent required.

Qualifications

• Five (5) years of progressively responsible experience in IVD or medical device industry required.
• Three (3) years of progressively responsible experience in Quality Assurance with at least two (2) years in quality compliance and/or Supplier Management activities required.

Ma Magement has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Advanced knowledge of current compliance requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, ISO 17025, IEC 60825 or other regulations and standards).
• Advanced knowledge of Corrective and Preventive Actions, Supplier Quality Management, Change Management, GMP and QMS principles, Supplier Quality Management, and Quality Events (Investigations, Deviations, Stop Shipments, and Nonconformances).
• Advanced ability to interpret and apply compliance and quality management requirements.
• Advanced ability to organize and complete multiple tasks in a fast-paced environment as a team member and/or as an individual contributor in a timely, accurate manner under general supervision.
• Advanced ability to function effectively with ambiguity in a rapidly changing environment.
• Advanced abilities in influence and negotiation while building collaborative relationships and maintaining strong, positive working relationships.
• Advanced ability to develop proactive and creative approaches to problem solving.
• Advanced skills in verbal and written communication including technical writing.
• Advanced skills in Microsoft Office Suite.

Travel requirements:

None.

The salary range for this position is currently $75,000-$100,000 annual. Individual compensation is based on the candidate's qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.

Work Environment (US only):

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect information. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard and telephone. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is active and requires varying levels of mobility.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com