Quality Manager

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Quality Manager – Clara
From our spirited entrepreneurial beginnings to our today’s global leadership position in the healthcare market, Nelipak has enjoyed 70 years of creating, shepherding, and leading the healthcare packaging industry – with plenty of significant milestones along the way. Nelipak Healthcare Packaging has 14 locations worldwide, and our sites ranging from 100-300 employees. We are exceeding industry standards and expectations; We are Quality; We are bespoke packaging solutions, no matter the challenge; and we are always at the forefront of the healthcare packaging industry.
Reporting to the Operations Director, and with a dotted line to Nelipak’s Director of Quality Europe, the Quality Manager is responsible to lead and manage a group of Quality professionals to ensure a high level of Quality Management Systems and regulatory compliance in the plant.
The Quality Manager will work alongside all other members of the Clara Site Leadership Team to achieve the site’s key performance metrics and deliver its strategic objectives.
Manage and develop the Clara Quality team against agreed targets and budgets according to company standards, policies and procedures (appraisals, discipline, training, development, etc.).
Develop and implement Quality Management strategy and plans, including resource, systems, timescales, financials, to support, contribute to, and integrate within, the organisation’s annual business plan and long-term strategy.
Develop, sustain and continuously improve the Nelipak Claras QMS in accordance with Company procedures and regulatory requirements. (ISO 13485, FDA 21 CFR Part 820, GMP/GDP, Customer Codes of Practice)
Identify and manage the Quality Budget, ensuring the reduction in risk from claims and all potential costs.
Act as site Management Representative responsible for the planning and execution of Management Review activities, including tracking and closure of action items.
Responsible for the timely processing and closure of customer feedback through the QMS Complaint process, escalating critical issues as appropriate.
Drive robust timely and effective corrective and preventive action programs through the CAPA system ensuring the use of appropriate problem-solving tools.
Develop and maintain internal audit program, lead and support third party audit.
Ensure compliance to Change control requirements, leading collaboratively and driving documented and timely change control within Claras QMS.
Identify, develop, and report QMS trending, metrics and KPIs. Enabling the Clara leadership team to have oversight of QMS effectiveness and input into Clara’s priorities and objectives.
Provide effective and timely communication of product quality issues, to ensure mitigation of risk.
Drive continuous improvement (CI) initiatives to enhance the Clara Quality System and ensure compliance to corporate policies and procedures.
Promote a culture of Quality first, ensuring continued focus on the developing awareness and positive engagement of all employees towards the continued improvement of Quality.

BS degree in Engineering/Science or other relevant field; Prefer Master’s Degree or equivalent additional coursework. [essential]
5-8 years’ experience in Quality Engineering in Medical Device or other regulated manufacturing environment (biotech, pharma, military/space). [essential]
Demonstrable experience in the use of Continuous Improvement activities e.g. Six Sigma techniques. [desirable]
Certified Quality Auditor; ASQ or ISO 13485. [desirable]
High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
Knowledge of regulatory requirements including ISO 14971, ISO 13485, and FDA Quality System

Working at Nelipak means being part of a community that values ​​innovation, teamwork, and making a difference in healthcare.
A Supportive Environment: A culture of support, teamwork, and mutual respect, where every member is encouraged to contribute.
Growth Opportunities: Commitment to your professional development, with opportunities to advance within the company.
Competitive Compensation: A competitive salary and an attractive benefits package that reflects your expertise and contribution.
Impactful Work: The opportunity to play a crucial role in delivering innovative packaging solutions that truly make a difference in healthcare.

Paid Annual Leave Days and Sick Days

Nelipak i s an equal opportunity and inclusive employer.
For a confidential discussion, or to apply, please contact Clara HR at . Please note, if you apply for this role, your interest and details will remain confidential. We will not contact your current employer as part of the application. Due to the urgency of this role, candidates must be eligible to work in the jobs location to be considered for this role. The duties listed for this role are not exclusive or exhaustive, and the job holder shall perform the duties that can reasonably be expected within the scope of the position.
The above list of responsibilities is not exhaustive, and the job holder will be required to perform tasks that can reasonably be expected within the scope of the role.
Speak to a Nelipak commercial sales representative about how Nelipak’s Performance Packaging solutions are right for any and all sensitive medical products.
Our business partnerships is built upon helping our clients successfully build brands, sell products and deliver their products successfully to market. We will work with your team to deliver on time and on budget – from concept to end-use, we’re with you through it all.
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