Job Summary

Autoimmunity Managers are responsible for planning and managing the operations of their assigned department to ensure successful operations in compliance with Quality Systems and other Regulatory, Human Resources, and Legal requirements, as well as all company policies. Responsible for ensuring department goals are met and budgets are managed. Responsible for implementing and improving processes, procedures and policies that enable and encourage optimum performance of the people and resources within assigned area.
Responsible for managing and leading the work of direct and indirect reports, both individual contributors and people managers. Activities are performed in accordance with standard operating procedures (SOPs), Quality Systems Regulations (QSRs), Human Resources, EHS and other company policies. As a member of the Werfen management team is responsible for role modeling Werfen Values and Role of the Manager competencies and expectations.

Within Quality Engineering, the Manager position is responsible for the following, under the direction of Department Leadership. Responsible for leading a team of technical staff to advise and assist in developing, applying, and implementing methods, tools, and practices to achieve product quality goals and requirements in the areas of new product development, as well as production, testing, distribution, maintenance, and support of on-market products. Provides leadership, support, and input to the organization related to design assurance, risk management, design changes, component and process quality, problem solving, statistical techniques, test method development, non-conforming product investigations, corrective and preventive actions, and continuous improvement.

Key Accountabilities

• Teamwork: Coordinate with Department Leadership and other cross-functional areas including R&D, Manufacturing, and Quality Assurance to establish priorities and goals for design and development projects, risk management, failure analysis, process validation, product capability, trend analysis, and statistical process controls. Model effective team collaboration behavior.
• Product and Process Life Cycle: Assist Department Leadership in developing, improving, implementing, and maintaining Quality Management procedures that ensure design and development, production, and post-production (post-market) activities that efficiently define, meet, and maintain customer, technical requirements, and regulatory requirements with objective evidence in accordance with applicable regulations and standards, per company goals. Assist Leadership in defining and driving improvement projects and initiatives that reduce systemic manufacturing defects.
• Risk Management: Maintain current knowledge of applicable requirements for risk management activities and produce audit ready risk file documents in compliance with the requirements of current international risk management standards and regulations. Coordinate evaluation of new and emerging risk standards. Assist in the development of plans for meeting and complying with new risk regulations, guidance, and standards.
• Quality Science and Engineering: Perform independent quality review and evaluation of change orders including related data for scientific approach, presence of supporting objective evidence, technical validity, accuracy, completeness, and compliance to applicable regulations and standards. Provide direction from a quality perspective for cross-functional interactions regarding process and product compliance/quality optimization. Provide input to product requirements, acceptance criteria, process monitoring, product evaluation, failure investigation, and complaint analysis. Ensure appropriate statistical tools and techniques are followed. Collect and analyze defined quality metrics and quality-related data to identify issues or trends.
• Quality Management Systems: Identify applicable processes for new standards and regulations. Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards. Aid in designing and documenting new and revised quality systems for product realization compliance with applicable regulations and standards. Escalate events that may contribute negatively to medical device safety or efficacy. Address and remediate events that may contribute negatively to QMS processes or effectiveness.
• Audit: Support internal, and third-party audits, regulatory inspection preparation and execution. Assist in closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions.
• Department Planning: Establish and monitor strategies, priorities and goals for risk management, process validation, process reliability, trend analysis, statistical methods and ensure initiatives are successfully implemented under the guidance of the Director of Quality Engineering. Provide back-up support for Quality Engineering team.
• Department Management: Responsible for overall performance of department operations, personnel and budget. Leads department to achieve department and company goals. Responsible for quality of hiring, development and performance of team. Ensure a culture of accountability, teamwork, collaboration, continuous improvement and compliance to company policies and procedures, legal requirements and the Quality System. Ensure effective performance management and development activities are completed, including onboarding, training, setting expectations, and providing meaningful feedback. Maintain regular and transparent communications through effective use of one- on-one meetings, team meetings and other forms of formal and informal communications. Proactively manage employee relations issues; use judgement in consulting with department leadership and Human Resources. May include managing people managers to ensure business acumen, commitment to Werfen Values, as well as Role of the Manager comptencies & expectations.

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

Networking/Key Relationships

• Manufacturing teams
• R&D teams
• Regulatory Affairs
• Other Werfen Technology Center Quality Engineering functions
• Marketing teams
• Quality Assurance teams
• Product Testing team
• Post-market compliance team

Minimum Knowledge & Experience

Education:

• Bachelor’s degree or equivalent experience required; bioengineering, biochemistry, chemistry, molecular biology, or related technical science discipline required. Advanced degree preferred.
• ASQ Certifications for Certified Quality Engineer (CQE), Certified Medical Device Auditor (CMDA), Six sigma black belt, or Certified Quality Manager (CQM) preferred.

Experience:

• Minium of 5 years' experience in an in vitro diagnostics environment required of which 2 should be in Quality Engineering or related roles with risk management, problem solving, and root cause analysis methodologies required.
• 5+ years’ experience supervising or managing an operational team required, including responsibility to staffing management and development, budget management and compliance with policies & regulations.
• Technical writing experience required.
• Experience in IVD systems development (integrating reagent, instrumentation, and software) preferred.
• Experience in design and development, technology transfer, risk management, verification and validation, statistical analysis techniques required.
• Experience with data collection, data analysis/evaluation, and scientific method required.

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

Skills & Capabilities

• Ability to apply, review, and interpret statistical methods in alignment with the Quality Management System and industry quality standards.
• Ability to lead cross-functional projects to a timely and effective conclusion.
• Ability to act quickly and decisively.
• Ability to manage and coordinate the activities of direct reports.
• Demonstrated knowledge in ISO 13485, ISO 14971, 21 CFR 802, EU 2017/746.
• Demonstrated leadership abilities with a focus on collaboration and teamwork.
• Ability to function effectively with ambiguity in a rapidly changing environment.
• Ability to develop proactive and creative approaches to problem solving.
• Ability to interpret and apply compliance and quality management requirements.
• Advanced ability to organize and complete multiple tasks in a fast-paced environment.
• Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat.

Travel Requirements:
<10% of time

Work Environment:

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 scientific data. 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, telephone and pipettes or other lab equipment.  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 and/or move up to 25 pounds.  The noise level in the work environment will vary but is usually moderate. 

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The salary range for this position is currently $90,000- $175,000 annually. 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.