MINIMUM QUALIFICATION REQUIREMENTS
- Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
- Bachelor of Science Degree in Engineering, preferred.Experience
- Minimum 10 years experience in Quality, Regulatory Affairs, Manufacturing or Engineering within regulated industry (e.g. medical device, pharmaceutical).
- Knowledge and experience interpreting and applying global regulations and standards for Quality Management System.
- Extensive knowledge of and experience in the following areas (within area of responsibility):
- Quality System elements including Management Controls, Document Management, Material Controls and CAPA
- Quality System elements including Production and Process Controls (e.g. Sterilization, Facilities Controls, Equipment Controls, Validation, Acceptance Criteria
- Quality System elements including Design Controls and Risk Management
- Successful completion of global projects involving stakeholders from multiple regions (North America, Latin America, Asia-Pacific, EMEA) strongly preferred.
- Demonstrated skill ability to develop and implement compliant and efficient processes.
- Strong interactive skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
- Represents the organization as the prime technical contact on the work stream. Interacts with senior level external associates on significant design work, requirements gathering and review.
- Driver for acquiring resources and building consensus across projects.
- Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
- Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
- Demonstrated ability to communicate effectively both verbally and in writing.
- Ability and willingness to work on multiple topics at one time.
- Demonstrated ability to effectively lead and manage core teams.
- Demonstrated ability to develop and maintain the overall project vision and strategy while managing the tactical details and activities.
- Demonstrated facilitation skills to effect project progress per plan.
- Ability to manage conflicts; to read situations quickly; to lead by influence; to exploit opportunities; and to find common ground and get cooperation with minimum noise.
- Knowledge and use of relevant PC software applications and skills to use them effectively, including Microsoft Project schedules
An equivalent competency level acquired through a variation of these qualifications may be considered.
The area of responsibility is Risk Management and Design Controls. This includes the following duties and preferred skills:
- Manage design and implementation of the Risk Management and Design Controls processes within a new global quality system in accordance with department, regulatory, and professional standards for compliance (ISO 13485:2003, ISO 14971, MDD, CMDR, FDA Quality System Regulations).
- Comprehensive knowledge of U.S., European and other international regulations, standards and guidance applicable to medical devices and pharmaceuticals (e.g. ISO 13485:2016, ISO 14971:2012, 21 CFR 803, 21 CFR 820, 21 CFR 210 & 211, ICH Q7, MDD, MEDDEV 2.12, MHLW, etc.).
- Serves as expert and main point of contact for global regulations, standards and processes within area of Risk Mangement and Design Controls, ensuring processes are compliant and effective.
- Develops and implements risk based strategy for procedures and processes across the company as they relate to Verification and Validation activities, acceptance criteria, production processes and controls including material/supplier control, CAPA/post market activities, and regulatory changes and impacts.
- Successful completion of global projects involving stakeholders from multiple regions (North America, Latin America, Asia-Pacific, EMEA) preferred.
- Capability to interact with diplomacy and tact while maintaining appropriate assertiveness.
- Ensure interface and alignment throughout the product realization process and during the entire product life cycle including post-market surveillance for consistent decision making and actions across all functional areas.
- Experience with Essential Design Outputs and Critical component criteria preferred.
- Candidates with experience in embedded product software or stand alone software preferred.
Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Additional Physical Requirements
Requires travel based on business needs.