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Job Requirements of Manager, Quality Assurance:
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Employment Type:
Full-Time
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Location:
Gilbert, AZ (Onsite)
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Manager, Quality Assurance
CooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com
RA/QA Manager oversees all activities reacted to regulatory affairs and quality assurance for the CooperVision SEC Sherbrooke site to ensure compliance with applicable regulations and maintenance of current certificates. It is responsible for advising and consulting with stakeholders about compliance.
This position is the Management Representative for the site.
Job Summary:
Manages and communicates with CVI management concerning all major regulatory affairs and quality system issues related to manufacturing, design control and compliance with applicable regulations. The QA/RA Manager will research, recommend, and implement best practices, and contribute to both the strategic and operational functions for the site.
The RA/QA Manager also shares the responsibilities of the Person Responsible for Regulatory Compliance with RAQA Specialist and is responsible for the clauses of Article 15 (3) of the EU Medical Devices Regulation (MDR) 2017/745.
Responsibilities
Essential Functions & Accountabilities:
- Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
- Writes, reviews and approves as needed validation protocols (e.g. IQ, OQ PQ) for manufacturing equipment and processes.
- Prepares and reviews changes to Quality Manual, Device Master Records, and product technical files, communicating same to all departments involved.
- Manages the internal audit program at Paragon to ensure compliance with applicable regulations.
- Reviews, evaluates, and resolves customer complaints for quality related problems. Implements corrective actions as necessary.
- Acts as management representative for all FDA inspections, ISO audits and other external audits.
- Reviews and approves all new vendors related to the quality system. Monitors and assesses reported vendor performance problems from all personnel that conduct purchasing. Conducts purchasing of all QA inspectional equipment and supplies.
- Manages all QA activities with regards to direct reports, final inspections, document control, and coordinates quality control activities with manufacturing.
- Maintains and improves product quality by ensuring QA compliance; surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
- Works closely with Marketing and Clinical Affairs to set priorities and strategies to meet business needs.
- Regulatory Intelligence: Keeps ahead of US FDA, Canadian, EU MDR and other applicable regulatory requirements and changes within the regulatory registration processes. Advises management on future International regulations, based upon thorough knowledge of applicable regulations.
- Reviews and approves Regulatory Assessment documents, as required for post-market change control.
- Collaborates with direct supervisor to create and manage department budget:
- Obtain quotes for consultants
- Predicts costs for future submissions based on business forecast
- Predicts costs for tests that fall under department budget
- Manage costs to stay within defined budget.
- Builds, develops, and supervises quality and regulatory affairs staff. Provides training and professional development opportunities to direct reports. Provides guidance on regulatory requirements to strengthen scientific validity of submissions and receive timely product approvals, marketing clearances, and/or product registrations and licenses.
- Responsibilities to include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving employee problems.
Travel Requirements:
- Up to 10% domestically and/or internationally.
Qualifications
Knowledge, Skills and Abilities:
- Strong leadership skills characterized by the ability to collaborate with others in order to drive results.
- Also valued are the abilities to look at the big picture, to understand technical details, as well as to have a good sense for business.
- Excellent communication (both verbal and written) and human relation skills. Fluent command of spoken and written English.
- Excellent project management skills, with ability to prioritize and handle several projects concurrently.
- High organizational agility to quickly adapt to change and redirect resources effectively and appropriately. Ability to work under pressure and adhere to deadlines.
- Strong organizational skills; realizes the importance of time management and prioritization in order to maintain a high level of personal efficiency to meet the demands of a fast-paced environment.
- Highest levels of personal and professional integrity and ethics, and unquestioned integrity in each of his/her initiatives.
- High analytical evaluation skills.
- Computer proficiency in Microsoft Office required, including: Word, Excel, PowerPoint, Project, Outlook and Visio.
Work Environment:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Light lifting of documents, files, and reference books.
- Able to generate large volumes of documents in a fast-paced environment; troubleshoots printer, frequent walking to and from the printer room, and be able to produce electronic records on demand.
- Able to work long periods of time in a normal office environment, while sitting and working on a computer.
Experience:
- Minimum of 5 years of experience in the Medical Devices Industry
- Strong knowledge of regulatory requirements related to product registration processes for Medical Devices.
- Application of quality system and regulatory requirements from product concept through product distribution.
- Working knowledge of interacting with regulatory entities, notified bodies, and other external regulators.
- Contact Lens experience is highly desirable
- Works effectively across different cultures and languages
- Strong technical acumen, computer skills, problem solving ability, analytical, writing and communication skills
Education:
- B.Sc. in Chemical / Biochemical / Biotechnology / Materials Science Engineering
- Internal and Lead auditor certification
Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran
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Recommended Skills
- Adaptability
- Agility
- Analytical
- Auditing
- Biotechnology
- Business Requirements
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