Post Market Quality Engineer

Unomedical s.r.o.

Place of work
Priemyselný park 3, Michalovce
Contract type
full-time
Start date
by agreement

Information about the position

Job description, responsibilities and duties

The Post Market Quality Engineer is responsible and accountable for quality engineering deliverables required within the post market compliance & surveillance processes. Act as steward for post-market safety and quality, customer requirements/expectations, and regulatory compliance. Overall responsibility for ensuring technical rigor and compliance to applicable procedures during risk management, complaint, CAPA, and design related processes. Serve as liaison between marketing, manufacturing, quality, and R&D to ensure post-market safety and performance are maintained for all product franchises.

Duties and Responsibilities:
• Support quality engineering activities for all post market product surveillance including collection, analysis, and evaluation of product safety and performance data, and detection of trends in data that may warrant further action
• Execute and maintain procedures and processes to address post-market surveillance activities such as product investigations, periodic and ad hoc risk reviews, and product monitoring (trending and tracking) across all product franchises
• Develop understanding of the current risk profile for all products including reportable product harms and malfunctions
• Review and update risk management files for completeness and accuracy
• Participate in design control activities and provide input into identifying failure modes and risk assessment for new and existing products while providing expertise in product complaint history and occurrence levels
• Support investigations arising from CAPA, complaints, Health Hazard Evaluations (HHE), Internal audits, third party inspections, and other business processes by applying typical quality/problem solving tools such as fishbone/cause & effect, Pareto, process mapping, etc.
• Support continuous improvement of quality engineering procedures, processes, and tools

Basic wage component (gross) and other rewards

minimum 1100€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company

Information about the selection process

Please send your CV only in english language.

Only candidates who meet our requirements will be invited for the interview. Data of not selected candidates will be deleted in compliance with GDPR and data protection law.

Information about personal data processing of job seekers is located on link: http://www.convatec.sk/o-nás/kariéra/

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)

Educational Specialization

in Engineering

Language skills

English - Upper intermediate (B2)

Number of years of experience

5

Personality requirements and skills

• preferably Certified Quality Engineer (CQE), Six Sigma, Project Management training and/or certifications

Experience:
• 5+ years or equivalent experience in quality engineering role in a medical device or life sciences technology driven company
• Experience with various phases of the product development lifecycle including concept, design, implementation, verification, and validation activities necessary for product commercialization.
• Experience in product and process risk management
• Experience in manufacturing processes within a medical device company - advantage
• Experience in post-market surveillance activities (tracking and trending, investigations)
• Significant regulatory and compliance knowledge and expertise in quality systems and medical devices: QSR Part 820, ISO 13485, MDD 93/42, GMP Parts 201 and 211

Competencies:
• High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
• Excellent communications, presentation, and facilitation skills
• Ability to work within cross-functional team environments
• Support a positive working environment that encourages creative thinking and intelligent decision-making
• Proficient with software such as Word, Excel, Powerpoint, Project, Visio as well as statistical tools (e.g. Minitab)
• Passion for ongoing product and compliance learning as well as skills enhancement

Advertiser

Brief description of the company

ConvaTec is a global medical products and technologies company, with leading market positions in ostomy care, wound therapeutics, continence and critical care, and infusion devices. Our products provide a range of clinical and economic benefits, including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care.

Number of employees

500-999 employees

Company address

Unomedical, s. r. o.
Priemyselný park 3
071 01 Michalovce
http://www.convatec.sk

Contact

Contact person: Peter Leško
Tel.: +421566815125
E-mail: send CV
ID: 3686971   Dátum zverejnenia: 6.6.2019   Základná zložka mzdy (brutto) a ďalšie odmeny:   minimum 1100€ / monthly (depending on experiences and quality of the candidate) + quarterly bonus and other benefits in compliance with social benefit program of the company