QA/RA Manager

SpectraCures affärsidé är att med sitt egenutvecklade och patentsökta system behandla inre solida cancertumörer, förlänga överlevnaden för cancerpatienter, samt att verka som kompletterande behandlingsalternativ till andra cancerbehandlingar.

Behandlingsystemet lämpar sig för behandling av inre solida tumörer och som ett första steg har systemet anpassats för behandling av återfall av prostatacancer. I dagsläget är behandlingen av återfall av prostatacancer omstridd då flera metoder medför allvarliga biverkningar.

SpectraCures metod bygger på fotodynamisk terapi (PDT), vilket innebär att vävnaden görs ljuskänslig med hjälp av ett läkemedel. Läkemedlet aktiveras sedan med laserljus för att eliminera cancercellerna.

För mer information gå gärna in på företagets hemsida: https://spectracure.se/

Tjänsten: QA/RA Manager PRRC and Management Representative
Placering: SpectraCure i Lund

The QA/RA Manager will play an important role in actively supporting the company in all QA related issues as well as act as Person Responsible for Regulatory Compliance (PRRC). You will have responsibility for SpectraCure's Quality Management System (QMS), deliver solutions to aid compliance within the daily work, support colleagues in quality issues, and encourage and improve the QA mindset in the company. High emphasis will be put on QMS maintenance, interaction with relevant authorities globally, giving advice and reporting to management on QA issues.

The QA/RA Manager has a very important function to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements. You need to be good at analyzing data and translating the outcome to actions.

Furthermore, part of the role is to coordinate and support audits, conducted by external providers or authorities, both during audits and follow-up of findings and corrective actions. In addition, you will also perform external audits, e.g. suppliers, in close collaboration with relevant stakeholders.

We are looking for a dedicated and driven person, with excellent communication skills, as the position involves many interactions, both internally and externally. You are goal- and results-oriented, have a structured approach and enjoy working in teams.

You will report directly to CEO and have close interactions with CTO.

Responsibilites
• Ensure compliance with SpectraCure QMS and applicable laws, regulations, standards and guidance’s
• Responsible for conformance of SpectraCure QMS to applicable regulations, standards and guidelines (mainly MDR 2017/745 and international standards such as ISO 13485 and ISO 14971)
• Develop, document, implement and maintain necessary processes and procedures needed for the QMS and to ensure that the specified product quality will be achieved
• Responsible for QA aspects of nonconformity, complaint handling, CAPA and change control
• Collect and compile data and information related to the effectiveness of the QMS and any need for improvement and will report the status to Top Management at the Management reviews
• Ensure the organization´s awareness of the quality management system and applicable regulatory requirements
• Responsible for ensuring that internal audit programs are being developed
• Responsible for the relations with external parties such as Notified Body Regulatory Authorities and/or suppliers to the QMS or other stakeholders
• Perform the role of a Person Responsible for Regulatory Compliance (PRRC)

Tasks
• Maintain and improve the Quality Management System (QMS)
• Ensure awareness of personnel of quality releated issues. Ensure effective implementation including training of the QMS for personnel.
• Collect and compile data and information related to the quality management system
• Initiate improvements and changes to SpectraCure routines and procedures
• Manage the CAPA handling processes
• Review and approve documentation within area of responsibility. Compile and archive quality documents and product documentation and keep document index up to date.
• Assist in preparation and review release documentation for SpectraCure products
• Plan, perform and report internal audits as well as subcontractor/supplier quality audits
• Approval of supplier evaluations
• Participate as quality representative in development projects
• Assist in compiling and submission of applications to notified body and regulatory authorities
• Surveillance of new or revised regulatory requirements. Identify own training needs within area of responsibility. Participate in training according to individual training plan.
• Follow procedures established in the SpectraCure Quality Management System as well as laws and regulations

Requirements
• Academic degree within Life/Health Science
• Knowledge and work experience with ISO 13485 Quality Management System
• Knowledge and training in the Medical Device Regulation 2017/745
• Knowledge, training and work experience with internal audit of QMS, supplier/subcontractor audits
• Knowledge and work experience with risk management system ISO 14971
• Fluent in English and Swedish
• IT skills, proficient with Microsoft Office products

Required skills and personal characteristics
• Takes initiative, acts with confidence, and works under own direction. Makes prompt, clear decisions which may involve tough choices or considered risks.
• Establishes good relationships with customers and staff. Builds wide and effective networks of contacts inside and outside the organization.
• Uses technology to achieve work objectives. Ability to translate and communicate QA requirements to all staff.
• Sets high standards for quality and quantity, works in a systematic, methodical, and orderly way
• Adapts to changing circumstances and works productively in a high-demanding environment
• We believe that you are proactive, communicative and committed to your way of working and that you can adapt to different kinds of people and situations
• As a person, we hope that you are curious, outgoing and can easily move between different tasks and systems
• You pay attention to details, have a structured way of working and can handle several tasks at the same time, even when the pace is high
• As a person, you are professional and have strong integrity
• You have good communication skills orally and in writing, you are independent, responsible and without prestige
• You are determined and customer-focused and deliver the desired results on time

Opportunities
• Be part of the company’s vision, to eliminate internal cancer tumors and improve the quality of life for cancer patients
• Be part of a dedicated team in a fast-growing global highly innovative listed company with an informal and non-prestige corporate culture. The company is located in modern premises in the central part of Lund.
• Work with great "freedom under responsibility" and the possibility to influence
• Work for an attractive employer with focus on well-being, collaboration, fellowship and personal development. The company offers solid conditions and good benefits for employment.

Attractive Employer with focus on
• Wellbeing
• Co-determination
• Cooperation
• Fellowship
• Personal development
• Offers solid terms and good benefits for employment

Corporate culture and values
• Commitment – For each other and others
• Trust - In our treatment method and collective competence
• Community - To keep hearts beating

HOW WE CREATE COMMUNITY
• We encourage each other - everyone can have a bad day and then a colleague's encouraging words mean a lot
• We celebrate each other's successes. We are a team where everyone's contribution is important.
• We are responsive and support each other when needed
• We always show respect when meeting each other and keep a good tone

Contact
For more information, please contact

Catharina Herbertsson, Senior Rekryteringskonsult
Catharina.herbertsson@peaksearch.se
+46 (0)70 615 27 72

Eva Runnerström, Senior Rekryteringskonsult
Eva.runnerstrom@peaksearch.se
+46 (0)70 172 53 79