Product Quality Specialist
3 days ago
UK
- Full-time
- Position Type: Permanent
**Business Title: Product Quality Specialist - Medical Device**
**Role Summary**
- Reporting to the EMEA Business Quality Head, the Product Quality Specialist is a technical expert in regulatory requirements, standards, and best practices in one or more regulatory classification areas.
- This position is responsible for quality oversight of new product launches, and product changes, ensuring to maintain high quality and applicable compliance.
- This position will work closely with R&D, Regulatory, Analytical, Manufacturing Plant Quality and Operations to support the on-time launch of new products and changes and influence these functions in the development of a new product quality plan and change control documents.
- The position is also a major contributor to issue resolution utilizing quality engineering skills to ensure on-time commercialization. This position is responsible for reviewing, approving and releasing first to market products/improvements.
**Strategy and Functional Expertise**
- Knowledge of policies, procedures and metrics
- Standard computer-based software knowledge
- Keeps accurate documentation and submits detailed reports to appropriate executives
- Skills in data analysis to report and present effectiveness of business processes
- High attention to detail, organization, and accuracy
- Numeracy abilities and working knowledge of data analysis/statistical methods
**Leadership and Influence**
- Well organized and demonstrates forward thinking and high initiative
- Ability to influence cross functionally to deliver against business goals and objectives
- Leads and directs strategic programs focused on meeting regulatory company requirements
- Manages and develops other members of the team
- Mentors’ others in technical areas of expertise
- Demonstrates broad business orientation
- Shows personal commitment to the vision and creates energy and optimism
**Program Development/Program Management**
- Tests, confirms and/or improves processes to ensure they are in control and being followed
- Estimate, track and complete projects on time and within budget
- Participate in the product functional analysis (based on standard) to translate customer specifications and internal requirements into clear product performance criteria
- Participate in DFMEA processes (based on standards) and make sure tests that are identified as recommended actions are incorporated
- Perform root cause analysis and resolve problems Solves issues quickly and efficiently
- Give the necessary inputs to the Design Engineer to ensure that the design meets the defined performance
- Provide technical expertise and engineering excellence to medical device product development projects
- Ensures Stakeholder Satisfaction
- Delivers project tasks on time
- Works cross-functionally to identify and communicate compliance & regulatory requirements
- Works cross-functionally to influence others to align with new requirements
- Oversees implementation to ensure adherence to new requirements
- Set requirements for suppliers and monitor their compliance
- Oversee all product development procedures to identify deviations from quality standards
- Monitors spend and identifies additional project needs
- Evaluates Project Performance
- Ability to prioritize and handle multiple projects simultaneously
- Communicates and engages appropriately with vendors/suppliers
- Conducts sensitive conversations in a confidential manner with venders/suppliers
- Maintains sensitivity of communication with internal and external entities (e.g. stakeholders, venders, suppliers)
- Monitors progress by maintaining dialogue on work and results
- Makes good and timely decisions that keep the organization moving forward
**Impact/Reach**
- Strong execution skills
- Demonstrates agility and connectivity across the organization
- Actively builds connections and partnerships with others, internally and externally
- Ability to work with all levels of PD, supply chain, technology teams to build relationships across functions
**Education and Experience**
- University’s degree from an accredited institution in Science, Engineering, or a related field
- Professional typically with over 8 years of technical experience and a demonstrated track record
- Transitioning to Generalist in at least 1 area: Consumer products, medical devices, food, dietary supplements or pharmaceutical
- Contributions focused on some strategic initiative as well as functional execution elements; starting to work independently and transition to people management
- May be consulted internally as an expert in the area of functional expertise
**Skills and Competencies**
- Familiarity with MDD, MDR, 21 CFR 820, ISO 13485, ISO 14971, IEC 60601 and IEC 62304 is also highly desired
- Clear understanding of manufacturing process including development PpK, CpK and IQ/OQ/PQ
- Excellent verbal and written skills; ability to analyze, define and effectively convey
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