QA Supervisor

Location:

Roosendaal (NL – 4879) – Netherlands

Salary:

Competitive

Type:

Permanent

Main Industry:

Search Finance, Banking & Insurance Jobs

Other Industries & Skills: 

Manufacturing, Property & Real Estate

Advertiser:

Hollister Incorporated

Job ID:

130239095

Posted On: 

22 March 2024

We Make Life More Rewarding and Dignified 

Location: Roosendaal 
Department: Quality 

Summary:

The position will provide QA leadership and vision as part of a cross functional facility Leadership Team, striving for a dynamic Culture of Quality to continuously improve our products, processes and Quality Management System (QMS) to best fulfil our Mission and Vision and make life more rewarding and dignified for the people who use our products. They will support the Roosendaal facility and also align with the global Quality organization to achieve business objectives.

Responsibilities:

-The Quality Assurance Supervisor will directly oversee the activity of the QA department and staff. As part of this responsibility, they will generate and maintain a plan for the professional development and coaching of all direct reports including annual goal setting.
-Develop and maintain an overall strategy for their QA function ensuring communication to key stakeholders for alignment.
-Responsibility for developing, implementing, and maintaining the QMS  for the organizations products and processes ensuring audit readiness and compliance is maintained in line with required standards, regulations and company procedures.
-Quality oversight for finished goods product release where applicable including returns handling and re-work activities.
-Quality oversight for change control, complaints, internal audit, risk management, notified body/health authority external audits
-Quality oversight for the introduction of changes to existing products and of new innovative products.
-Support on the sites continuous improvement program ( HPS) ensuring the quality function work towards efficient and effective processes.
-Provide QA technical direction and guidance to achieve company objectives.
-Support the preparation and management of the QA operating budget in conjunction with the Facility Manager.
-Decision making authority with respect to product quality in consultation with key stakeholders.
-Participate in facility Leadership Meetings as required.
-Represent the site as Management Representative/Authorized Representative/Person Responsible for Regulatory Compliance as outlined in Medical Device regulations if required.
-Support vendor approval/ evaluation for the EDC as required.
-Other duties as required.

Work Experience Requirements:

-Number of Overall Years Necessary: 8-12
-5+ years’ experience in a Medical Device/Pharma Industry in a Quality role that includes personnel and Quality System leadership.
 

Education Requirements

-Bachelor degree in Quality/Science/Engineering/ Logistics or a significant level of relevant experience.
 

Specialized Skills/Technical Knowledge:

-Thorough Knowledge of Quality Management system elements and associated regulatory requirements (ISO 13485, ISO 14971, FDA 820.30, MDD/MDR etc.)
-Knowledge of internal & external audit management with proven experience in representing a company in interactions with notified body/Regulatory agencies.
-Good working knowledge of continuous improvement and root cause problem solving.
-Demonstrated ability to project manage and execute tasks in a timely and efficient manner.
-Must be able to communicate (both written and verbal) at all levels of the organization and with customers, suppliers and regulatory agencies.
-Good interpersonal skills with the ability to work as part of a cross functional team.
-Excellent analytical skills with an ability to define problems, analyze through data collection/fact finding and draw valid conclusions in a timely manner.
-Have a continuous improvement mindset and demonstrated change management skills.
 

Local Specifications:

-English
 

About Hollister Incorporated

Hollister Incorporated is an independent, employee-owned company that develops, manufactures and markets healthcare products worldwide. The company spearheads the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings. Find out more at Hollister

Hollister is an EO employer – M/F/Veteran/Disability
Job Req ID:

32558

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