Supplier Quality Manager
Our client, a medical device company in Cork are currently looking to recruit a Chemical Manufacturing Engineer for their site.
The Supplier Quality Manager will:
- Lead development, continuous improvement and implementation of supplier control processes within responsible Quality System's that meet regulatory requirements and align with J&J standards.
- Recruit, develop and manage the company supplier quality team to ensure a high performing team to achieve the group's objectives
- Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities, and CAPA and change management.
- Ensure effective and timely investigation and closure of all CAPA's, Supplier Non Conformances, complaints, product issues.
- Lead Supplier Quality input to site management reviews
- Partner with Business R&D and Design Quality to ensure new product sourcing and supplier controls are implemented in line with business and J&J requirements
- Supports third party assessments at both the company and suppliers.
- Provide Quality Leadership in support of supplier and External Manufacturing Outsourcing programs and product transfers to suppliers
- Partner with site Management teams to meet site SQ related objectives
- Provide SQ input to and attend supplier business reviews as required
- Responsible for ensuring the supplier audit schedule is achieved
- Drive a standardised approach by leading the Supplier Management Committee meetings for responsible sites
- Maintain and control the list of approved suppliers for sites within responsible sites
- Maintain and Control Company SOPs in support of initial supplier approval and continuous supplier evaluation and in compliance with MD&D Supplier quality requirements
- Maintain supplier management documentation and records to ensure they are complete and current
- Promote continuous improvement and Process Excellence activities within the company Supplier Quality Management group
- Work to ensure supplier engineering resources are prioritised in support of business and quality aims
- Actively drive all defined Supplier and External Manufacturing Quality Systems goals and objectives.
- Design and validate Quality System processes where appropriate
- Participate in design evaluations where appropriate
- Resolve problems & eliminate constraints to ensure project and supply targets are met.
- Generate Quality metrics on supplier performance and establish measures to monitor quality
- Maintain standards of housekeeping & GMP requirements
- Represent the Supply Process Quality Assurance function as required by management
- Ensure that all Health, Safety and Environmental requirements are fulfilled.
- Maintain detailed and accurate records of all activities
- A minimum of a Bachelor's degree in engineering/scientific or associated relevant technical / engineering discipline is required.
- An Advanced degree in engineering/scientific or discipline is preferred.
- A minimum of 5 years progressive quality, engineering or operations experience in a regulated industry is required.
- A minimum of 2 years' experience in a managerial capacity is preferred.
- Previous work experience with Suppliers is preferred.
- Demonstrated knowledge of business impact of compliance issues and risk management is required.
- Experience in leadership roles involving project management, problem solving and technical projects is required.
- This individual is required to possess high performing skills in negotiating and influencing decision makers, decision making skills, communication skills, and judgement, tact and leadership skills.
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