Product Quality Specialist - Folkestone, United Kingdom - BioTalent

BioTalent

Verified Company

Folkestone, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

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Description

Fulltime
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 ontime 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 ontime 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 computerbased 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 crossfunctionally to identify and communicate compliance & regulatory requirements
Works crossfunctionally 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