Product Quality Specialist

4 weeks ago

Folkestone, United Kingdom BioTalent Full time

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

  • Product Quality Specialist

    4 weeks ago

    Folkestone, United Kingdom BioTalent Full time

    Position Summary - UK - Full-time - Hybrid - Position Type: Permanent **Business Title: Product Quality Specialist - Cosmetics & Pharma** - 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...

  • Quality Specialist Trainer

    16 hours ago

    Folkestone, United Kingdom Church & Dwight Full time

    Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the...

  • Engineering Controls and Automation Specialist

    1 month ago

    Folkestone, United Kingdom Kandhu Ltd Full time

    An Engineering Controls and Automation Specialist is needed for this highly successful manufacturing business. OPPORTUNITY HIGHLIGHTS - Job Security - highly successful business - Monday - Friday role (requirements for flexibility on weekends/evening working depending on projects) - Competitive Salary - Fantastic benefits THE ENGINEERING CONTROLS AND...

  • Contract Manufacturing Quality Lead

    14 hours ago

    Folkestone, United Kingdom Church & Dwight Full time

    Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the...

  • International Logistics Fulfilment Specialist

    1 month ago

    Folkestone, United Kingdom Kandhu Ltd Full time

    An experienced International Logistics Fulfilment Specialist is required for a highly successful FMCG business. OPPORTUNITY HIGHLIGHTS - 22 Month FTC - Competitive Salary - Excellent benefits - Hybrid role - 50% working from home and 50% working in the office. THE INTERNATIONAL LOGISTICS FULFILMENT SPECIALIST - The International Logistics Fulfilment...

  • European Head of Quality

    4 weeks ago

    Folkestone, United Kingdom Church & Dwight Full time

    Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the...

  • Production Operator

    3 weeks ago

    Folkestone, United Kingdom Church & Dwight Full time

    Job Description A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the...

  • Carpenter Folkestone

    4 weeks ago

    Folkestone, United Kingdom Hays Specialist Recruitment Limited Full time

    FOLKESTONE CARPENTER JOBS FOLKESTONE CARPENTER JOBS FOLKESTONE CARPENTER NEEDED 1st fix and 2nd Fix Carpenters needed in Folkestone Basic Requirements High quality Carpentry and Mitring skills Own tools Numerous years experience Well presented and punctual Please call Marcus at Hays on or FOLKESTONE CARPENTER NEEDED FOLKESTONE CARPENTRY TOOLS AND...

  • Contracts Specialist with Italian Language

    2 weeks ago

    Folkestone, United Kingdom Swiss Re Full time

    About the Role Additionally what you can look for is: • Serving as a trained specialist for both external clients and internal partners to steer contractual issues to resolution. • Meeting expectations with respect to quality and turnaround time of advice and deliverables, ., standard treaty provisions and rationale, develop/recommend alternative...

  • European Head of Quality

    3 weeks ago

    Folkestone, Kent, United Kingdom Church & Dwight Co., Inc. Full time

    A collective energy and ambition. A place where you can make a real difference. We’re a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take...

  • Account Operation Specialist

    3 days ago

    Folkestone, Kent, United Kingdom Swiss Re Full time

    Do you have a passion for numbers, enjoying working with data and Excel, and looking to work for the company where you can make a global impact? Join our department as an Account Operation Specialist and build your career with us About the team As a team, we are the guardians of the data and cash and the first line in managing data before it flows through...

  • Quality and Performance Data Officer

    3 weeks ago

    Folkestone, Kent, United Kingdom Church & Dwight Co., Inc. Full time

    A collective energy and ambition. Are you an experienced quality professional looking for a new challenge? Do you have a track record of successfully implementing quality and compliance strategies? Church & Dwight UK Ltd. are currently seeking a highly skilled and experienced individual to fill the position of Head of European Quality. As the European Head...

  • Account Operation Specialist

    16 hours ago

    Folkestone, United Kingdom Swiss RE Full time

    Do you have a passion for numbers, enjoying working with data and Excel, and looking to work for the company where you can make a global impact? Join our department as an Account Operation Specialist and build your career with us! **About the team** As a team, we are the guardians of the data and cash and the first line in managing data before it flows...

  • Quality control operative

    2 weeks ago

    Folkestone, Kent, United Kingdom Morgan Jones Recruitment Consultants Full time

    Quality Inspector (x2) 28 Per Hour to start during probation rising to £13.02 per hour thereafter Permanent Have you the ability to read Engineering Drawings? Our client is a highly successful manufacturing business providing a sub-contract component and assembly service to the Industry. They are looking for Quality Inspectors to ensure products are...

  • Multi Skilled Engineer

    1 month ago

    Folkestone, United Kingdom Kandhu Ltd Full time

    An ELECTRICALLY biased Maintenance Engineer is needed for this highly successful manufacturing business. This will be a 4 on 4 off shift pattern which includes days and nights, working 12-hour shifts. OPPORTUNITY HIGHLIGHTS - Job Security - highly successful business - 4 on 4 off shift pattern - days and nights - 12 hour shifts - Competitive Salary -...

  • Account Operation Specialist

    2 days ago

    Folkestone, United Kingdom Swiss Re Full time

    Do you have a passion for numbers, enjoying working with data and Excel, and looking to work for the company where you can make a global impact? Join our department as an Account Operation Specialist and build your career with us! About the team As a team, we are the guardians of the data and cash and the first line in managing data before it flows...

  • Multi-Skilled Engineer

    4 weeks ago

    Folkestone, United Kingdom Kandhu Recruitment Ltd Full time

    An ELECTRICALLY biased Maintenance Engineer is needed for this highly successful manufacturing business. This will be a 4 on 4 off shift pattern which includes days and nights, working 12-hour shifts. OPPORTUNITY HIGHLIGHTS Job Security - highly successful business 4 on 4 off shift pattern - days and nights - 12 hour shifts Competitive Salary Fantastic...

  • English and Art Teacher

    1 month ago

    Folkestone, United Kingdom Liquid Personnel Full time

    **Start date: ASAP** The English and Art curricula span Entry Level, Functional Skills, Key stage 3, and GCSE. **Your benefits as an English and Art Teacher**: - Being a part of a progressive and forward-thinking organisation, which puts children first. - Competitive salary - Annual performance reviews with opportunity for development and salary increase -...

  • Multi-Skilled Engineer

    3 weeks ago

    Folkestone, United Kingdom Kandhu Recruitment Ltd Full time

    An ELECTRICALLY biased Maintenance Engineer is needed for this highly successful manufacturing business. This will be a 4 on 4 off shift pattern which includes days and nights, working 12-hour shifts.OPPORTUNITY HIGHLIGHTSJob Security - highly successful business 4 on 4 off shift pattern - days and nights - 12 hour shiftsCompetitive SalaryFantastic benefits ...

  • Multi-Skilled Engineer

    4 weeks ago

    Folkestone, United Kingdom Kandhu Recruitment Ltd Full time

    An ELECTRICALLY biased Maintenance Engineer is needed for this highly successful manufacturing business. This will be a 4 on 4 off shift pattern which includes days and nights, working 12-hour shifts.OPPORTUNITY HIGHLIGHTSJob Security - highly successful business 4 on 4 off shift pattern - days and nights - 12 hour shiftsCompetitive SalaryFantastic...