Job Description
Title:
Group Quality Manager.
Location:
Based at Cambridge (R&D) and Huntingdon (Manufacturing).
Purpose of Role:
The role is responsible for developing and administering the Quality
Management System (QMS) throughout the group.
Ensuring compliance to ISO 9000 for the manufacturing sites, the role will
also develop the QMS to ISO9000 standards within Cambridge (R&D, Sales,
and Marketing).
Reporting
Relationships:
Reporting into the Director of Quality.
Key
Accountabilities:
Accountability:
Measure of Success:
To maintain alignment of key
procedures, processes and
practices with the Cambridge,
Huntingdon and Sweden sites.
Key procedures shared between all
sites; in particular:
Quality Policy & Manual, Control of
Documents, Control of Records,
Calibration, Identification &
Traceability, Control of Non-Conforming
Products, Internal Audit, Training
Records; Corrective Action & Preventive
Action (CAPA), change control and
process validation.
New procedures defined and owned by
process owners and key staff effectively
trained.
Conduct and maintain a Gap
Analysis to determine the
development needed in the R&D
and Product Management
procedures to develop a
pragmatic and workable Product
Design oriented QMS.
Design, develop and maintain the
Document Control system;
manage the Quality
Administration for Document
Control.
Initially Cambridge but expand
site wide.
Document Control system with unique
document numbering system, common
format and ONLY one approved version
of a document in existence.
Once developed, extend system to
Huntingdon and Sweden. Users trained.
Job Description
Design develop and maintain a
Software and Firmware Control
system; manage the Quality
Administration for Software
Control
Define and implement best
practice through the
development of business
procedures & processes.
Develop pragmatic procedures
for the Design Control of
products capturing best practice.
Ensure R&D processes/ activities
are effectively integrated with
development projects Product
Lifecycle requirements.
Schedule and carry out audits
against the business systems and
report findings.
Report & drive timely close-out
of any corrective actions.
Key Internal
Relationships:
All S/W uniquely identified with full
history traceable. Test methodologies
defined. Users Trained.
Develop a practical and robust QMS to
support on-going business
requirements.
Effectively communicated and
implemented across the business
Ability to solicit and gain input from
other and write technical documents
(Procedures and Policies).
Timely implementation of new products
meeting quality requirements and
adequate design and development
records maintained.
Produce audit reports and improvement
/ development plans. Demonstrate
effectiveness of audits and
improvement activities.
Timely close-out of corrective actions
Audits & reviews conducted to plan.
Liaise with all external regulation Compliance to all relevant legislations
bodies ensuring compliance (to
(CE mark) and effective communication
industry standards and
across the business.
legislation and communication of
requirements across the
business.
Manage and prioritise your
Effective prioritisations of team
teams activities to ensure
activities.
business requirements are met
and communicate status
Trained and motivated teams.
Teams:
Quality Administration
Meeting business requirements.
Validation & Analysis
QA Technicians
Other site Quality Assurance Managers and Quality Engineers, Design
Engineering Teams, Process Engineering Teams, Operational Management
and Head Office Functions.
Job Description
Key Challenges:
Person
Specification:
Qualifications
and experience
Coping with a varying workload and effective prioritisation of yourself and
your teams.
Driving business systems improvements across Design Functions and R&D.
 Will be in a Senior Quality Management Role within an R&D focused
business.
 Must have strong experience of Quality Management in Design and
Development processes and high technology manufacturing, in
particular Design Specification, Review, Control and Technology
Transfer.
 Strong leader with initiative and decision making capabilities , will be
highly analytical and have an assertive yet persuasive style that will
enable change in a complex organisation.
 Pragmatic approach to solving problems, a creative thinker willing to
challenge conventional thinking through development of alternative
solutions.
 Strong communicator (verbal and written) with proven leadership and
management skills.
Minimum Degree qualification (Mechanical / Electronics) or equivalent
CQI (Chartered Quality Institute) qualified or equivalent .
Significant experience in Quality Management and systems improvement in
a manufacturing and development environment.
Experience of implementing and maintaining Quality Management Systems.
Six Sigma qualified, and or familiar with statistics and Design of Experience
procedures.
Lead Auditor qualified (Quality Systems) – desirable / not essential