Engineering & Electronics
Quality Program Manager
PE Global is currently recruiting for a Quality Program Manager on behalf of our client based in Cork. This is an initial 12-month contract role.
In this leadership role the Quality Make Program Manager will be responsible for collaborating with the SC EUMDR teams to develop the overall Make strategy globally; align with leadership teams Joints; Quality Make; Franchise and drive implementation globally. You will lead a global quality team to develop the overall Make tech file submission strategy and implement globally based on aligning stakeholders such as SQH and Regional Leads. Influencing and communication at senior level on overall global program will be a key deliverable of this role and allow the individual opportunities to grow in this space and showcase his/her leadership skills.
- Shape and develop the Quality Make EU MDR Roadmap and Lead Global Implementation
- Lead global quality team to develop EUMDR rollout plan in collaborating with engineering site representative and global EUMDR team for key aspect such as:
- Article 18 implementation (new implant cards & labeling requirements) – develop best global strategy and lead site implementation though quality team globally
- Understand Multivariant EUMDR strategy and assess impact globally & ensure overall business initiatives interdependences understood, with communication to site stakeholders as required to align position
- Ensure all quality deliverables met to achieve successful submission to notified bodies per committed timelines and requirements
- Provide executive summary updates to key stakeholders such at Joints; Franchise; and Quality Make Leadership teams as well at the EUMDR leadership team
- Lead development of global risk-management strategy for Quality Make to support EUMDR tech file submissions:
- Collaborate with manufacturing engineering; design teams and regulatory to develop strategy and gain support within the organization to developed strategy
- Influence appropriate leadership teams to supported resulting roadmap and gain alignment globally to same with SQH etc
- Lead team of quality engineers in collaborating with engineering to implement riskbased strategy
- Define ownership and accountability of risk assessment process including conducting, documenting, reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes as part of overall strategy
- Review & ensure QS procedures and controls are in compliance to standards such as the QSRs, ISO 13485, etc and comply with the recognized Regulatory Standard
- Communicate executive summary to broad stakeholder Leadership teams of EUMDR; Joints; Franchisee; Quality. Propose solutions/roadmaps to any new emerging challenges and influence leadership teams to support as needed
- As program manager ensure key metrics of timelines; budget; resourcing plans are communicated and progressing to plan using project mgmt. tools to track progress of global team
Education and Experience:
- A minimum of a Bachelor’s Degree, preferably in Engineering/Science or related technical field. Generally, requires 8-10 years related experience including 4-6 years specific experience in a management/supervisory role.
- Demonstrated project management and project leadership abilities are required.
- Strong influencer with demonstrated track record of developing strategy and aligning stakeholders and team members to support and deliver
- Can provide support with technical trade-off decisions required to achieve desired results using demonstrated risk-based approach
- This position will require relevant experience working in manufacturing/operations.
- Good knowledge of product/process Risk Management (FDA and ISO standards) is required
- The ability to perform “hands on” troubleshooting and problem solving is required. The ability to think on the feet and providing sound judgment is high desired.
- Excellent technical understanding of manufacturing equipment and processes is preferred.
- A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
- EU MDR knowledge and understanding is preferred
- Strong mentoring, coaching and leadership skills are required.
- Experience in supervising and directing the work of others is required.
- Ability to manage resources remotely.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***