Quality Specialist
Quality Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
About the Role:
Provides quality support for multiple projects within CTLS LLC. including process improvement Quality Management System (QMS) Operations and R&D. Supports quality initiatives advanced operations and quality process improvements.
Responsibilities:
Supports compliance with regulatory standards including ISO 13485 and 21 CFR Part 820.
Assist with Quality Management System (QMS) reviews approvals and updates.
Assist with regulatory and supplier audits as necessary.
Assist with investigations related to Complaints CAPAs Non-conformances and SCARs.
Responsible for the upkeep of all DHF files.
Assist with key quality and engineering activities such as dFMEA pFMEA documentation creation review and approvals ensuring compliance to Good Manufacturing Practice (GMP) Standards.
Provide support to validation activities process risk assessment inspection processes and continuous improvement initiatives.
Help improve and drive performance of quality processes to meet quality and site KPIs.
Assist with project related document and technical review and approval.
Collaborate with cross functional teams to ensure quality is maintained throughout the production process.
Ensure the safety and quality of products and procedures by assisting with inspection quality control measures and identifying areas of improvement.
Collaborate with cross functional teams to address quality issues drive continuous improvement and contribute to creating high-quality products to ensure customer satisfaction.
Assist with identifying product and/or production issues.
Assist with quality assurance activities and creating reports for management.
Collaborate with internal and external team members while maintaining professionalism.
Demonstrate the highest quality standards and embrace the Convatec core mission values and priorities.
#LI-Onsite
#LI-JF
Qualifications:
Bachelors degree (B.S.) or equivalent in related field.
Previous experience within the medical device field.
Knowledge of FDA and ISO regulations.
Two to four years related experience or equivalent.
Strong organizational problem-solving and analytical skills.
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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race religion creed color national origin nationality citizenship ancestry sex age marital status physical or mental disability affectional or sexual orientation gender identity military or veteran status genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec employee
If you are an active employee at Convatec please do not apply here. Go to the Career Worklet on your Workday home page and View Convatec Internal Career Site - Find Jobs. Thank you!
Required Experience:
Unclear Seniority
Employment Type
Full-Time
