Quality Engineer (Senior)
Almelo, Overijssel, NetherlandsQuality Management
Do you enjoy playing a crucial role in the realization of innovative products that enhance safety, health or convenience? Then this may be an excellent opportunity.
As a (Senior) Quality Assurance Engineer at Benchmark you will work within the Operations department where both New Product Introduction (NPI) and New Product Launch (NPL) come together. Depending on the project scope Benchmark can be both Contract Designer and Contract Manufacturer and the product development, New Product Development (NPD), that precedes NPI takes place at the Design Engineering department or the product design is provided by the customer.
As Quality Assurance Engineer, you act as the conscience for one or more customer programs in terms of quality. You are a critical sparring partner of the program manager and part of the multidisciplinary project team. In addition, you are in close contact with your colleagues from the Quality Assurance & Regulatory Affairs (QARA) department.
You play a crucial role in ensuring that the high-tech products resulting from NPI and NPL are effective for the desired application and meet customer requirements. For this specific vacancy we are looking for reinforcement for the Medical market segment. Within Medical you will be the QA representative for a broad customer and product portfolio. The common denominator is that these are complex products that are used by our customers in very important places after release. Examples include in-vitro diagnostic (IVD) devices, life-sustaining and vitals monitoring devices, and connected digital health solutions. Not for nothing is the slogan of Benchmark: "when it matters".
Your focus within Benchmark is on NPI, which is seen as an integral part of the product realization. In the translation of customer requirements into product concepts and detailed product design, by Design Engineering department, you are involved from NPI. During NPI activities, it is important that there is good synergy between product and process design to ensure that volume production can proceed effectively and efficiently (NPL). As product design matures, there will be more emphasis on NPI and thus the manufacturing process, associated production setup and release.
What you can add:
Our customers require the complex solutions to be designed, developed and produced to a high level of quality.
As the conscience of the customer program, your job as Quality Assurance Engineer is to ensure that what is delivered by the multidisciplinary project teams meets the desired level before they can count on your approval.
You coach and inspire project teams in reaching the desired level and pushing the ambitions. In which it is important to find a balance between involvement on the one hand and independence and authority on the other towards the project teams.
It is also important that you know how to view the dynamics in the project teams from different perspectives and aggregation levels, always keeping the ultimate goal in sight while keeping an eye for structural improvements.
How you add value
You are curious and eager to learn and therefore master trends and the development of new quality principles, standards, laws and regulations for the medical market segment and implement them pragmatically in customer programs.
- You ensure that clear agreements are made with internal (e.g. Program Management, Regulatory Affairs) and external (e.g. customer) stakeholders.
- You ensure that project execution is in line with agreed internal and external agreements (contracts and agreements, QMS, etc.).
- You ensure that the output of NPD/NPI and volume activities is in accordance with the agreed specifications
- You take responsibility for ensuring quality assurance within customer programs and coaching all colleagues for the benefit of quality and quality perception for the medical market segment.
- You are an authority in your field and use this to the benefit of the project teams. As a result, you bring clarity and contribute to realizing progress within the permissible frameworks of internal and external requirements.
- You are able to come up with creative and effective solutions together with our clients.
- You are the driving force behind initiating improvement initiatives across all disciplines.
- You develop yourself by challenging yourself and learning from mistakes.
How to add value
- You supervise projects and processes from your independent role.
- You coach project teams in analyzing and solving problems.
- You maintain an overview, see connections and keep the bigger goal in mind.
- You bring clarity with regard to standards and regulations.
- You are an authority in your field and you do this for the benefit of the project teams.
We are looking for a new colleague with
- At least a completed Bachelor's degree (e.g. direction Technical Business Administration, Technical Medicine, Biomedical Technology or related);
- 1 to 3 years of work experience within the field.
- Interest in manufacturing products for regulated markets (Medical), and associated standards and laws and regulations such as: MDR/IVDR, FDA 21 CFR 820, ISO 13485.
- Knowledge of QA processes (including 8D Problem Solving).
- Strong analytical thinking skills that in the process is confident enough to raise issues and force improvements.
- A curious nature and the competence to master a lot of complex subject matter in a short period of time.
- Ambition and eagerness to further professionalize the organization.
- A decisive, proactive and results-oriented mindset.
- Drive to have a crucial role in professionalizing the medical market segment.
A work environment where you are part of a global company. Here you will work in independent teams where we are open to new initiatives and ideas from everyone. You will work in a dynamic environment that offers you the space to make quick steps, to grow, also through our Benchmark Academy and to get responsibility. These steps are possible within and outside your current job area. Within this environment, the work is not only challenging, but above all fun.
We offer excellent conditions in addition to an appropriate salary such as:
- 27 vacation days and 13 atv days.
- Flexible working hours. As long as you make sure your work gets done, there is a possibility within Benchmark to arrange your working hours in a flexible way.
- Broad development opportunities. Within Benchmark there are numerous opportunities for development.
- Entrepreneurship is seen, appreciated and stimulated.
Benchmark in Almelo is part of the multinational company Benchmark Electronics Inc., a listed company in the field of manufacturing electronics and providing services to original equipment manufacturers (OEMs). At Benchmark you work for companies that make an impact with their innovations, developing new products that increase safety, health or convenience. They deliver these products from product design to volume production and even directly to the end user. This entire process, from design to production, is carried out entirely in Almelo. Currently, Benchmark Inc. has 23 locations. In Almelo we have around 620 employees.
Have you become interested in working at a fast-growing, internationally operating project organization? Then apply immediately! Are you looking for more information? Please contact Manon Voskamp via email@example.com.
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