Quality Assurance Engineer

Align Technology; Wrocław; On-site; PLN 120,000 - 180,000; Full time

Job summary

Align Technology in Wroclaw, Poland, is seeking a Quality Assurance professional to lead QA/QC activities across the manufacturing site, including CAPA, audits, complaint handling, supplier evaluation, and documentation control.

You will define requirements for process changes, ensure compliance with ISO 13485 and MDR, and drive continuous improvement with cross-functional teams. Fluent English and Polish are required; medical device experience preferred.

Qualifications

• Bachelor degree in chemistry, engineering or quality.
• Minimum 2+ years in quality/compliance (Medical or regulated).
• Knowledge of quality system regulations (21 CFR, ISO 13485, MDR 2017/745, GMP).
• Fluent English and Polish.

Responsibilities

• Quality assurance and control activities for the manufacturing site.
• Support CAPA, audit activities, complaint handling, and supplier evaluation.
• Define requirements for process changes and validation with local teams.
• Interpret regulatory requirements and industry standards.
• Coordinate documentation control and change control processes.
• Lead continuous improvement initiatives for quality across sites.

Skills

Quality management

Problem solving

Statistics

MS Office

Communication

ISO 13485

Production processes

Validation methods

English proficiency

Polish proficiency

Education

Bachelor's degree in chemistry, engineering or quality

Tools

MS Project

Minitab

Job description

Description

This position is responsible for all quality assurance and control activities for the manufacturing site and ensures support for other manufacturing departments in quality-related processes such as CAPA, audit, complaint handling, supplier evaluation, etc.

Key Responsibilities

• Support business in product quality and environmental aspects in dedicated areas (SLA/AFAB/CSP/Shipping/Warehousing).
• Local partner for discussion for the business in PS groups / PFMEAs/ NCs/ CAPAs in relation to product quality and safety/environmental 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.
• Supporting 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.
• Responsible for working with appropriate staff from various departments to investigate root causes, put corrective action in place, and monitor results (coordinates 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.
• Carry out and participate in audits (internal, supplier ones) in order to verify the Quality Management System compliance.
• Responsible for ensuring 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 the process owners and stakeholders.
• Ensure the 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.
• Be responsible for maintaining and ensuring the site change control process in Align EDMS, including the review of change control documents and deliverables.
• Review and 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‑administration of Aligns EDMS documentation system.
• Create and maintain all hard and soft copy master files for active and archival documentation.
• Perform other duties as assigned.

Skills, Knowledge & Expertise

• Bachelor degree in relevant area (chemistry, engineering, quality) required as minimum.
• Post graduate studies related to Quality Management area nice to have.
• Minimum of 2+ 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.).
• 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

• Private healthcare Luxmed.
• Multisport card.
• Private insurance.
• Meal vouchers.
• Co‑financing of company products.
• Employee Support Program.
• Performance bonus.

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Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.