Quality Assurance Manager

Randstad Professionals is actively looking for a Quality Assurance Manager to join their pharmaceutical client in Oberdorf Baselland, Switzerland.

General Job description
Working in the Design Quality team the qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility.
This individual should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take action, and have excellent written and verbal communication skills. This position will also provide technical quality engineering leadership to the business in order to ensure the highest levels of product quality, process, and systems integrity to the end customer.

Responsibilities:
- Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement.
- Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies.
- Conduct and lead design verification and validation activities.
- Conduct and lead design/process failure mode effects and analysis.
- Work closely with suppliers on the qualification of new parts and processes supporting product development as needed.
- Conduct assessments of new suppliers as part of project teams.
- Provides leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
- Provide leadership in the understanding of medical device regulations to other disciplines.
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
- Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.

Requirements
- A minimum of Bachelor's degree in engineering or related technical or scientific discipline with a minimum of 5 years of experience in related field is required.
- A Master's degree in a technical discipline is an asset.
- Excellent problem solving, decision-making, and root cause analysis skills are required.
- Experience with Blueprint reading/literacy including GD&T is required.
- Proven track record implementing Quality System improvements to meet compliance and overall business goals.
- Proficiency with the Microsoft Office Suite is required.
- Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.
- Previous experience in a medical device or a healthcare discipline is preferred.
- Previous Quality Engineering experience is preferred.
- Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred.
- Working knowledge of material science and mechanical product knowledge is preferred.
- Development and/or manufacturing experience is preferred.
- Knowledge of process and design excellence tools is preferred. Process Excellence certification is an asset.

Soft skills
-Interpersonal skills that foster conflict resolution are required.
- Ability to work in a team setting within Design Quality and cross-funcationally is required

Language:
English (must)
German preferred

If this role sparks your interest, don't hesitate to send in your application

Good to know you

Charlotte