Senior Manager
at Collins McNicholas
Galway, County Galway, Ireland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 27 May, 2024 | Not Specified | 01 Mar, 2024 | 5 year(s) or above | Medical Devices,Interpersonal Skills,Technical Ability,Manufacturing,Uncertainty,Teams | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
Sector: Engineering
Contact Email: michelle.mcinerney@collinsmcnicholas.ie
Job Ref: 22501
Our client a major multination based in Galway are looking for hire a Senior Manager - Design Assurance as they continue to expand operations.
REQUIREMENTS:
- Job requires extensive knowledge of Medical Devices and/or IVD design and manufacturing as well as experience in a fast-moving R&D environment.
- Proven track record of results managing projects in a highly regulated environment.
- Strong Leadership capability and ability to influence change balancing compliance with pragmatic
- Problem solving.
- Proven track record in delivering successful NPI programs on budget and on time.
- Proven track record in delivering Continuous Improvement programs.
- Must have strong technical ability and be articulate in message delivery.
- Ability to work and interact with several cultures across various time zones.
- Excellent written and verbal interpersonal skills to influence many diverse internal and external stakeholders.
- Ability to present complex technical information to Senior Management.
Education & Experience:
- Bachelor’s Degree – Engineering/Science/Life Sciences - Post graduate degree desirable.
- 5 years plus experience in a QA/R&D or other technical leadership role in a regulated environment.
- Experience managing in an environment with changing priorities and making appropriate risk-based decisions in the face of uncertainty.
- Experience managing a design assurance team is essential and preferably experience working with teams remotely.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
Responsibilities:
THE ROLE:
As Design Assurance Senior Manager you will be responsible for implementing and maintaining the effectiveness of the Design Controls systems across IDEM Manufacturing plants.
RESPONSIBILITIES:
- Develop and execute strategies to optimize Design Controls process within IDEM and ensure compliance and connectivity to the broader design assurance process requirements.
- Provide design assurance oversight to all functions operating in the New Product Introduction area.
- Define clear roles and responsibilities for all functions to ensure effective execution of the design controls process (R&D, RA, PM, Operations, Clinical).
- Ensure timely communication with VP of QA and Senior Leaders on critical design quality
- Manage resources to support product launches, appropriately matching skill set of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues and assuring successful project outcomes.
- Conduct/Coordinate regular and robust design reviews that provide assessment of issues, risks, and resource requirements for all phases of NPI projects.
- Ensure that product/process/package/label/Test Method designs and associated documentation comply with applicable Regulations for products distributed globally (US/OUS).
- Pro-actively monitor Post Market surveillance trends to ensure any potential design issues are addressed as well as developing a closed loop feedback system to the design process.
- Work closely with the R&D and Design Quality teams to ensure robust new product launch planning and successful design transfer process.
- Design Controls SME and person directly responsible to represent IDEM with outside Regulatory authorities (FDA, NMPA, Notified Bodies, MoH, WHO) on design quality.
- Participate in Regulatory Agency inspections and respond to queries related to product design controls, change control and complaints.
- Collaborate with Regulatory Affairs and R&D to establish appropriate product filing strategies and provide necessary product documentation for submission.
- Establish and execute design control policies, procedures, processes and principles to ensure robust product designs, appropriate evaluation during development and document change controls compliant with requirements.
- Collaborate with R&D in the development of Design test protocols and study plans and ensure both test plans and reports are compliant with all applicable regulatory requirements.
- Work with R&D to ensure that Product Test Methods are designed to provide the appropriate challenge to products and validated appropriately.
- Work with R&D to ensure successful and cost-effective product scale-up and technology transfer from R&D to commercial manufacture.
- Establish a post launch review process that monitors new product performance against the expected market performance and triggers escalation/intervention as necessary.
- Develop design assurance processes, systems, and Staff, delivering a high performing team that supports successful NPI execution across all IDEM Sites.
REQUIREMENT SUMMARY
Min:5.0Max:10.0 year(s)
Electrical/Electronic Manufacturing
Engineering Design / R&D
Other
Graduate
Proficient
1
Galway, County Galway, Ireland