Quality Assurance Engineer

Align Technology, Inc.; Polska; On-site; PLN 120,000 - 180,000; Full time

Job summary

A leading medical device company in Poland is looking for a Quality Assurance Engineer to oversee quality assurance and control activities. This role is critical in supporting various manufacturing departments and ensuring compliance with regulations. The ideal candidate will have at least 3 years of experience in a quality role, especially in regulated areas, and must be fluent in English and Polish. This position offers a comprehensive benefits package, including medical care and an annual bonus based on performance.

Benefits

Private medical care

Multisport card

Private life insurance

Social fund

Meal subsidies

Discounts on company products

Qualifications

• 3+ years of experience in a quality/compliance role, preferably in medical devices.
• Strong understanding of quality system regulations for medical devices.

Responsibilities

• Ensure compliance with all quality assurance and control activities.
• Support internal and cross-functional teams in quality improvement efforts.
• Conduct audits and participate in external inspections.

Skills

Problem solving

Production processes knowledge

Statistics (Minitab)

ISO 13485 knowledge

MS Office skills

Goal achieving focus

Education

Bachelor degree in chemistry, engineering, or quality

Post graduate studies related to Quality Management

Job description

Quality Assurance Engineer

Department: Quality

Employment Type: Full Time

Location: EMEA-Poland-AFAB

Description

JOB PURPOSE

This position is responsible for all quality assurance and control activities for manufacturing site and ensure support for other manufacturing departments in the field of quality related processes like: CAPA, audit, complaint handling, supplier evaluation etc.

Role expectations

MAIN RESPONSIBILITIES/DUTIES

• Support business in product quality and environmental aspects in dedicated area (SLA/AFAB/CSP/Shipping/Warehousing)
• Act as local partner for discussion for the business in PS groups / PFMEAs/ NCs/ CAPAs in relation to product quality and safety/env conditions
• Define requirements for process changes, validation purposes as interface with local teams
• Interpret and apply applicable regulatory agency regulations and industry standards
• Knowledge exchange and unify approach/procedures across Align sites and partner for discussion with other Align sites
• Identify, analyze and lead the implementation of continuous opportunities of improvement (process and/or quality) focused on exceeding customer needs
• Support internal and cross-functional teams in process quality improvement efforts
• Ensure that appropriate quality documentation is in place, implemented and effective and improve quality documentation based on needs
• Coordinate complaint handling and root cause investigation for local departments at the facility
• Work with appropriate staff from various departments to investigate root causes, put corrective action in place, and monitor results (coordinate CAPA activities locally)
• Carry out or participate in risk analysis regarding process, product or design
• Be involved in any Corporate or outside agency inspections relating to Quality Management System, if required
• Participate in audits (internal, supplier) in order to verify the Quality Management System compliance
• Ensure that appropriate quality controls are in place in the process
• Participate in proactive team efforts to achieve departmental and company goals
• Serve as general subject matter expert for quality processes & project teams
• Support, guide, and coach process owners and stakeholders
• Ensure effective fulfillment of quality objectives and deadlines assigned
• Ensure site document control procedures comply with local or country specific regulations as well as internal policies and procedures, translations of documents must be controlled
• Maintain and ensure site change control process in Align EDMS, including review of change control documents and deliverables
• Assist in resolution of documentation issues (e.g. change control, document archiving, procedures, etc.) and translations
• Review all electronic documents submitted to change control for correct formatting, spelling and clarity of text before obtaining approval
• Co-administer Aligns EDMS documentation system
• Create and maintain all hard and soft copy master files for active and archival documentation
• Perform other duties as assigned

What we're looking for

ACADEMIC BACKGROUND

• Bachelor degree in relevant area (chemistry, engineering, quality) required as minimum
• Post graduate studies related to Quality Management area nice to have

REQUIRED EXPERIENCE

• Minimum of 3+ years of experience in a quality/compliance role (Medical or other regulated areas)
• A broad understanding of the Quality System regulations for medical devices (21 CFR, ISO 13485, MDR 2017/745, GMP, etc.)

LANGUAGES

• Strong written and oral communication abilities required and ability to synthesize information to present as requested
• Fluent English and Polish required (reading, writing, and conversation)

SKILLS /COMPETENCIES

• Practical knowledge of problem solving tools
• Production processes and validation methods knowledge
• Statistics (Minitab) and SPC knowledge
• ISO 13485 knowledge
• Very good MS Office tools skills (MS Project as well)
• Goal achieving focus

SPECIFIC CERTIFICATIONS/SPECIALTIES/COURSEWORK

• ISO 13485 Internal Auditor certificate nice to have

Job Benefits & Offer Details

This range includes an estimated base salary, covering various levels of experience for the role. Additionally, the position is eligible for an annual bonus of up to 10% of the annual base salary.

The final offer is determined based on the scope of the role, level of responsibility, experience, education, completed training, and key competencies of the candidate.

Align Technology, in addition to statutory benefits, provides a comprehensive set of perks designed to support employee comfort and professional development. Available benefits include, among others: private medical care through Luxmed, a Multisport card, private life insurance, a social fund, meal subsidies, and discounts on company products.

The annual bonus is awarded based on several criteria, including individual performance and company results. The range of additional benefits may vary depending on the position level, nature of work, and work location.

Information regarding compensation policies and salary ranges for this position can be found in the Compensation Policy available under the Corporate Disclaimers section of our careers site: https://jobs.aligntech.com/corporate-disclaimers

We encourage all candidates to review this document before moving forward in the recruitment process.