Ihre Aufgaben
- Manage and supervise a global team of 2-4 HHA Senior and Principal Engineers, ensuring the successful completion of HHAs.
- Oversee recruitment, training, and performance management of HHA engineers to ensure they meet team and organizational goals.
- Collaborate with cross-functional teams such as quality, regulatory, and engineering to track and ensure the timely completion of HHAs.
- Ensure that HHA target completion dates are met, addressing any delays or issues proactively.
- Contribute to process documentation, including procedures, work instructions, and templates, to improve the effectiveness of the HHA process.
- Act as a delegate for the HHA Chair, stepping in as needed for decision-making and team discussions.
- Provide post-market risk management expertise to support the HHA team in evaluating and mitigating product risks.
- Lead and facilitate corrective actions (CAPAs) and non-conformance (NC) reports as necessary to resolve issues within the HHA process.
Ihre Qualifikationen
- Bachelor’s Degree in a technical or science-related field.
- At least 10 years of experience in the medical device or regulated industry, focusing on risk management, Health Hazard Assessments (HHAs), or corrective actions.
- A minimum of 5 years of experience in managing teams, including overseeing performance and workload distribution.
- In-depth knowledge of FDA QSRs, ISO 13485, ISO 14971, and 21 CFR 820 regulations.
- Proven ability to manage multiple projects simultaneously and meet deadlines.
- Strong verbal and written communication skills, with the ability to facilitate meetings and presentations.
- Excellent collaboration skills, with the ability to work across teams and cultures.
- Self-motivated with the ability to solve problems quickly and efficiently while maintaining a sense of urgency.
Ihre Vorteile
-30 days of annual leave
-Up to 60% mobile work possible + flexible work time model with overtime compensation
-Holiday and Christmas bonuses
-Corporate benefits discounts for employees
-Comprehensive company pension scheme and capital-forming benefits
-Company restaurant with live cooking and healthy food (subsidized)
-Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
-Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
-Various subsidized company sports groups and access to the inhouse company gym