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Quality Associate II
711 Park Avenue Medina, NY 14103 US
Job Description
I. SUMMARY:
This document outlines the employment prerequisites and job responsibilities for the Supplier Quality Associate II position.
II. ESSENTIAL FUNCTIONS:
This position has primary responsibility for driving overall quality performance throughout the supply chain.
Specific responsibilities include:
Develop and communicate expectations for quality performance, continuous improvement, quality systems, and process controls for both critical sustaining parts and new products.
As required, participate as an active member in the new products development team.
Perform and coordinate supplier: surveys, quality system, and process control assessments.
Work with purchasing to measure and communicate supplier performance on key metrics and the corresponding continuous improvement plans.
Collaborate with supplier representatives in establishing effective quality systems, process controls, and problem-solving methodologies.
Conduct process and component validations as applicable.
Monitor and drive corrective action and continuous improvement activities that directly impact performance for assigned suppliers.
Conduct or lead event investigations and root cause analyses relative to purchased materials and components.
Perform other duties as assigned.
III. QUALIFICATIONS, KNOWLEDGE, AND SKILLS REQUIRED
Knowledge & application of reading and understanding blueprints/technical drawings.
Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
Experience in manufacturing/quality assurance engineering in an FDA regulated environment.
Knowledge and working application of standard operating procedures.
Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.
Knowledge and working application of data entry and spreadsheet applications.
Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
Practical experience in metrology, test equipment, inspection and analysis techniques.
Desired experience is in the medical device industry development and deployment of Quality System and process controls and continuous improvement methods (QSR, ISO13485).
Desired CQE, CSSBB, CQA or initiative to complete certifications.
Primary/Secondary party compliance auditing experience.
Ability to multi-task and methodically manage projects.
Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
Effectively operate in and facilitate cross-functional teams with guidance.
Must be able to provide solutions that reflect understanding business objectives and cost implications.
Ability to: stand or walk for long periods, lift and carry at least 20 pounds, perform repetitive motions with hands/fingers.
Demonstrated strong analytical problem solving (CAPA), teaming, and communications/interpersonal skills.
Must be willing to travel as needed.
IV. EDUCATION/EXPERIENCE REQUIRED
Bachelors Degree required.
Lead Auditor training, ISO Lead Assessor training, with 1-2 years experience in auditing techniques, interpreting regulations and quality systems.
Minimum of 3-5 years of experience in Quality, or related field in the medical products industry.
V. PHYSICAL DEMANDS
Able to exert up to 10 pounds of force occasionally. Able to sit, stand, walk throughout the workday.
VI. WORK ENVIRONMENT
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Client is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
Wearing a static protective smock at all times while in the manufacturing work area.
Working in close proximity to other employees.
Working in an environment that is temperature and humidity controlled.
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.
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