• Creates and manages investigation plans to analyze and synthesize facts and data, develop and execute test plans, review data for patterns and anomalies, conduct cross-functional reviews of investigation information, summarize investigation results and conclusions, identify potential areas of improvement including control deficiencies or process gaps and opportunities for design improvement.
• Proactively integrates innovative ways of approaching issues to mitigate risks and reduce investigation durations.
• Utilizes root cause techniques and investigative best practices and contributes to the collective understanding of investigative trends, risks, issues, and solutions.
• Documents investigation plans and reports, develops materials to communicate the results of investigations, including root causes and recommended corrective and preventative actions to various stakeholders and different audiences.
• Provides investigation progress on a pre-determined schedule and periodically upon request.
• Keep abreast of regulations, standards, and investigative methodology trends.
• Understands and executes all relevant quality documents. Writes new manufacturing documents, Standard Operating Procedures and other quality documents and processes documents through the company enterprise resource planning (ERP) system, SAP.
• Provides training and guidance to junior members of the team and provides administrative support to department management, as needed. Interacts effectively, using tact and diplomacy, with diverse personalities including colleagues, collaborators and outside vendors, as needed
• Accurately maintains lab records and scientific reports with attention to detail.
• Provides support to department management on a variety of administrative activities, which may include schedule coordination, training, distribution of workflow through the team/department, serving as a subject matter expert, etc.
• Understands the safety, technical, recordkeeping and Quality Systems Regulations (QSR) aspects of their position.
• Ensures compliance with applicable Werfen AID standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.
• Reflects the values of Werfen in the 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

• Research & Development Teams
• Sales and Marketing Teams
• Manufacturing Teams
• Quality and Regulatory Teams

Education:

• Bachelor’s degree in scientific field required.

• 10+ years of experience working in medical device industry required.
• 4+ years of conducting investigations strongly preferred
• Experience working in the field of immunology diagnostic research and/or medical device development preferred.

Skills & Capabilities:

• Deep knowledge and experience following lab protocols, safety requirements and procedures.
• Proven ability to understand complex process flows and improving processes.
• Demonstrated experience using a variety of laboratory equipment.
• Six sigma techniques and project management experience.
• Organizational and multi-tasking skills.
• Team focused, collaborative and good communication.
• Adaptable, resilient, innovative, and detail oriented.

Travel requirements:

Less than 5%.

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.