Quality Specialist EMEA

Recruiter
Bard Limited
Location
Haywards Heath
Posted
11 Feb 2018
Closes
21 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
C.R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing close to 14,000 people around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.

We expect the highest levels of quality, integrity, service, and innovation from our employees - on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.

MISSION

To advance lives and the delivery of Healthcare by profitably developing, manufacturing and marketing value-driven products which meet the quality, integrity, service, and innovation expectations of our customers and patients while providing opportunities for our employees. As a result, we will optimize shareholder value and be a respected worldwide healthcare company.

PEOPLE DEAL

Advancing Lives and the Delivery of Health Care.

As an ambitious, entrepreneurial and growing business, Bard EMEA is the natural home for driven, ethical and accountable people that want to get noticed, make things happen and enjoy the rewards they truly deserve. Our people are independent and critical thinkers that thrive on the challenge of delivering sustainable growth and live by our values. At Bard EMEA, your commitment and hunger for results will enable you to achieve more, grow more and be more.

OUR PROMISES TO YOU

At Bard we want you to be entrepreneurial, enterprising & accountable - you're trusted to run your own area and create your own solutions. We have a direct link between results and reward - great achievements merit great rewards. Expect a fast pace, change and growth - you'll be busy, challenged and never bored! You can make a real impact and get noticed, we have a flat structure and accessible senior management. We ask that you think inclusively with a mindset that enjoys working across functions and divisions, sharing diverse cultures, perspectives and capabilities to find superior solutions for our business, our shareholders, our customers and the patients we serve.

SUMMARY OF POSITION WITH GENERAL RESPONSIBILITIES

A new and exciting opportunity for the position of Quality Specialist in EMEA has arisen.

Reporting to the Director Quality EMEA, the successful candidate will be supporting the development and implementation of Bard EMEA's Quality Management Systems and programs to ensure compliance with company policies and procedures and industry regulations and standards, including EU MDD 93/42/EEC and ISO 13485/ 9001. The position mainly focusses on and provides support to Quality Assurance and Quality Control activities related to Post Market Surveillance activities such as Vigilance Reporting.

ROLE

This role has three main objectives:

- Ensure compliance with European post-market Regulatory Affairs and Quality Assurance requirements in accordance with the Medical Devices Directive 93/42/EEC, in country regulations and registration requirements.
- Provide compliance and Quality System support to the Director QA, EMEA, to ensure Bard fulfils its obligations under the Medical Devices Directive 93/42/EEC and in country regulations
- Generate and manage post market QA metrics and provide training as required on key post-market QA business processes. As part of the main objectives, the following responsibilities are assigned to this role:

- Supports the process for submission of vigilance reports including the completion of the vigilance decision tree and refers complex reports to senior staff; supports the oversight and timely reporting of events, including metric generation and reporting.
- Determines vigilance reportability based on an understanding of the risks associated with product malfunction and with senior staff.
- Generates key QA EMEA metrics on weekly and monthly basis.
- Strives to meet Accuracy Goals and delivers data in a timely manner. Ensures data is collected through routine business processes and reviewed by senior staff for accuracy, timeliness, relevance, completeness, comprehension, and quality.
- Performs queries to provide complaint data and ad hoc trend analyses on reported product problems/complaints/ vigilance reporting and or other QA data.
- Supports the EMEA complaint handling process and serves as back up for IBCs as defined.
- Acts as formal back up for senior staff.
- Performs other duties as assigned.

QUALIFICATIONS REQUIRED

- In-depth understanding of requirements relating to (a) Quality Management Systems, in particular ISO 13485 and ISO 9001 and good understanding and knowledge of the Medical Devices Directive, 93/42/EEC, including post market surveillance activities.
- Good analytical skills; attention to detail and ability to manage multiple tasks and priorities at the same time.
- Excellent interpersonal, collaboration and relationship-building skills at all levels and across all functions of the organization. Adeptness at working as a part of an interdisciplinary team and skilled at negotiation and influencing others.
- Proactive behavior, forward thinking and passion for process management and driving efficiencies.
- Excellent communication (both written and verbal).
- Computer skills (Advanced with Microsoft Excel, Word, Outlook and PowerPoint).
- Ability to read and speak English; working knowledge of other European languages also helpful.

EDUCATION & EXPERIENCE

For this function a Bachelor's Degree along with a minimum of 2 years' experience in a medical device company (or regulated health industry) in a quality or regulatory function is required.

Qualified candidates will have experience in the following industry sector:

- Post Market Surveillance
- EU Medical Devices Directive
- Quality Management Systems
- Quality Control

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