Quality Engineer I - Planet Pharma : Job Details

Job Description Pay 35-43/h depending on experience HM's Top Needs:

Prior complaint investigation on Class III medical device.

Working under pressure and manage stress, able to achieve weekly goals in terms of closing all assigned complaints each week.

Attention to details, avoid repeating errors on routine tasks.

Education Required: B.S degreeYears' Experience Required: 0-2 years Primary Responsibilities

• Leads complaint investigations, conducts periodic trending of complaint data, evaluates negative trends, assesses risk to released products which aids in determining appropriate field actions and analyzes explants and returned products, as required.
• Collaborates with cross functional teams like customer quality experience management, clinical affairs, medical safety, R&D engineering and manufacturing to perform thorough complaint investigation.
• Prepares appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team.
• Partners with design assurance team on risk analysis of new products by reviewing files such as product hazard analysis, DFMECA, post market surveillance plan, risk management report, etc.
• Owns and maintains periodic safety update report (PSUR) by collaborating with several cross-functional teams for applicable devices.
• Develops solutions to unique issues with wide range of difficulty. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation across functions and/or businesses which may cause redirection.
• Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business.

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.