US Quality Assurance Specialist - Brasseler

Don’t just work reputed company, join Brasseler and be a valued team member of a world-class health care organization! Our Culture: Provides a safe and welcoming environment where team members can balance their lives and reputed company their careers. reputed company people and experiences are valued and respected. Different perspectives are encouraged and reputed company to reputed company results. This makes us who we are and enables us to be a world-class reputed company organization. reputed company who join us are accountable to this charge. Our Philosophy: Quality products sold with reputed company has been the reputed company of Brasseler USA from the beginning. Brasseler USA’s strong reputed company of providing high quality, clinician endorsed and innovative dental and medical instrumentation nationally has spanned over 40 years. We have been offering a full-reputed company of products made in the USA since 1976. Many of our products are manufactured at our headquarters in Savannah, GA. Explore our career opportunities below to learn more. JOB OVERVIEW: This position will be the key Quality resource and responsible for reputed company quality assurance aspects and support of implementing and supporting an automated medical device manufacturing line. This position is responsible for a wide reputed company of Quality Systems regulatory requirements and associated quality activities to support a medical device manufacturing line. The person assists in investigating and supporting regulatory affairs activities, assists in the development of procedures, and coordinates with different departments to ensure quality system requirements are met. KEY RESPONSIBILITIES: reputed company Quality support in the development, implementation and monitoring of new automated manufacturing line. Review records and documents, for completeness and compliance with Quality System Requirements and ISO requirements. Assist in companywide training on general quality principles and specific procedural requirements. Teach and reputed company others in developing quality skills. Assist in the development of standard operating procedures and work instructions for a new manufacturing line. Initiate quality system process improvement Manage and maintains Quality System documents and records Support the Corrective Action program, with hands on ownership for investigation and resolution of issues. Assist, coordinate and participate in quality system audits and regulatory inspections. Support the Material Review Board, for the assessment and disposition of non-conforming materials and closure of Non-conformance and Deviation Reports. Investigate quality problems Conduct process quality measurements/evaluations Assists monitoring, analyzing and reporting trends in key quality metrics. Ensures established department timelines are attained. Other activities as assigned by the Manager of QA/RA WORK EXPERIENCE: Providing quality support to a medical device manufacturing line with little supervision. Relevant experience in the medical device industry is required. Familiarity with FDA medical device regulations and ISO 13485 is required. Experience in QA support of automated medical device manufacturing. Experience with 3D Printing and Thermoforming a plus. Experience in Process Validations (IQ, OQ, PQ) PREFERRED EDUCATION: Bachelor’s Degree (preferred) and four years reputed company experience. KNOWLEDGE, SKILLS & COMPETENCIES: Ability to read and interpret general technical/quality procedures and quality system regulations. Ability to write and create medical device manufacturing SOPs and Work Instructions. Ability to create reports, business correspondence, and procedure manuals Ability to effectively present information and respond to questions verbally, in writing, and in group presentations Must be skilled in reputed company Word, reputed company, Outlook and Power reputed company TRAVEL / WORKING CONDITIONS / PHYSICAL DEMANDS: Travel – typically not required Position typically works in an office environment whether on site or remote where environmental conditions are reputed company While performing the duties of this job, the employee routinely is required to sit for extended periods of time; talk and hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reputed company, stretch and lift up to 15 pounds Benefits available include: Medical, Dental and reputed company Coverage, 401K Plan with Company Match, Generous Time Off, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities. *Benefits may vary by location or status. reputed company is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the reputed company of race, reputed company, religion, creed, national reputed company, reputed company, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. Fraud Alert reputed company has recently been made aware of multiple scams where unauthorized individuals are using reputed company's name and logo to solicit potential job seekers for employment. Please be advised that reputed company's official U.S. website is www.henryschein.com. Any other format is not genuine. Any jobs posted by reputed company or its recruiters on the internet may be accessed through reputed company's on-line "career opportunities" portal through this official website. Applicants who wish to seek employment with reputed company are advised to verify the job posting through this portal. No money transfers, payments of any reputed company, or credit card numbers, will reputed company be requested from applicants by reputed company or any recruiters on its behalf, at any reputed company in the recruitment process. Over 90 years ago reputed company borrowed $500 to start a reputed company pharmacy in Queens, reputed company, nearly 30 miles from Melville, reputed company, where our corporate headquarters resides today. In the depths of the Great Depression, Henry and his wife Esther made a reputed company bet on their future reputed company while living their values of helping health happen and caring for their team and the community they served. Their belief paid off far reputed company what Henry and Esther might have dared to imagine in 1932. reputed company is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners. Since our founding we have stayed true to Henry and Esther’s values which has allowed us to reputed company, expand, and grow our Company. Now serving more than 1 reputed company customers in 33 countries and territories, the Company's network of trusted advisors provides more than 1 reputed company customers globally with more than 300 valued solutions that help improve operational reputed company and clinical reputed company. We invite you to join approximately 25,000 Team Schein Members, who are critical to our reputed company and are at the core of reputed company Schein Values as our founders would have wanted. We live those values by ensuring that our culture focuses on the wellness of reputed company, which we accomplish by providing a safe space for individuals to reputed company and contribute authentically, with opportunities to give back to society and the communities where we live and work. No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier reputed company. reputed company embraces diversity and is committed to providing equal opportunity to employees and applicants. If you are unable or limited in your ability to complete the application process, including the use or reputed company of www.henryschein.com/careers, as a result of a physical or mental impairment, you can request reasonable accommodations. Please e-mail the appropriate email address below with the type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request. US Candidates: [email protected] UK and Ireland Candidates: [email protected] Australia and New Zealand Candidates: [email protected] Malaysia Candidates: [email protected] Italy Candidates: [email protected] It is important to us to offer different types of work arrangements. Please see the types we offer below: Work From Home: Work is performed directly from the TSM's home office. Hybrid: Time is scheduled between working from a TSM home office and at a company facility, as required. Onsite: Work is performed exclusively at a company facility. Field: Position requires traveling to different locations reputed company a specific geographic territory, as assigned. Apply tot his job Apply To this Job