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Quality engineering manager - Bartlett, United States - Olympus Corporation of the Americas
Description
Full job descriptionWorkplace Flexibility:
Onsite
Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together.
Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years.Our Purpose is to make people's lives healthier, safer, and more fulfilling.
Our Core Values are reflected in all we do:
Integrity – Empathy – Agility – Unity – Long-Term View
We deliver on our purpose and our core values by staying
True to Life.
Job Description
Oversee management responsibilities for Quality Engineers. Responsibilities to include, leadership and guidance; employee planning, and assigning work direction. May serve as a site Management Representative, as delegated.
Manage the execution of activities to ensure compliance with the OSTA and local Quality Systems, Regulatory requirements, and the business strategy of the company.
Leads Quality Projects and CAPAs. Supports and leads Change Orders, as needed.This position reports into the Director of Quality, Bartlett Operations, and also reports indirectly to Top Management at the Bartlett Repair site.
Job DutiesPromotes awareness and compliance to all relevant Quality and Regulatory requirements across the site.
Ensures that adequate equipment and supplies are provided, where needed,.and for appraising job results, including Quality related Productivity and Efficiency.
Supports operations to assist the efficient processing of Change Orders and processing of medical devices through their processes.Applies the requirements of the Quality System to processes, products or services for the site.
Ensures that inspections occur effectively and efficiently.
Manages calibration for equipment used by the site (overall but including quality, timeliness, and cost).
Ensures that Preventive Maintenance activities are performed for Quality equipment.
Manages audit preparedness, including internal audits and third-party audits.
Responsible for the compliance of the NCR process (including the timeliness and completeness of actions taken)
Leads MRB to ensure proper and timely disposition of non-conforming product (NCRs)
Ensures that metrics are provided for management review (CAPA Board, formal Quality Systems
Management Reviews, etc.).
Communicates significant issues to site senior management and corporate management and ensures that plans for correction are developed.
Take actions to achieve and maintain goals related to audit results (no Majors, etc.).
Job Qualifications
Required:
4-year degree in Engineering or other related science required.
Minimum of five (5) years experience in the Medical Device industry where the individual was responsible for ensuring either improved product quality, improved Quality compliance, or both with responsibility for others' compliance, timeliness, and/or efficiencies.
Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, and ISO 13485.Travel up to 10% of the time
All other essential related duties as required
Preferred:
Strong working knowledge of problem solving skills.
Excellent verbal and written communication skills demonstrated by ability to generate technical reports, and ability to make presentations to middle and upper management.
Why join Olympus?Here, people matter—our health, our happiness, and our lives.
Competitive salaries, annual bonus and 401(k)* with company match
Comprehensive Medical, Dental, Visions coverage effective on start date
24/7 Employee Assistance Program
Free virtual live and on-demand wellness classes
Work-life balance supportive culture with hybrid and remote roles
12 Paid Holidays
Educational Assistance
Parental Leave and Adoption Assistance
Volunteering and charitable donation match programs
Diversity & Inclusion Programs including Colleague Affinity Networks
On-Site Child Daycare, Café, Fitness Center**US Only
**Limited locations
We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you.
Learn more about our benefit offerings atAbout us:
Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.
Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
For more information, visitOlympus is dedicated to building a diverse, inclusive and authentic workplace
We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect.
We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.
Let's realize your potential, together.It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Applicants with Disabilities:
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus
Posting Notes:
|| United States (US) || Tennessee (US-TN) || Bartlett || Quality & Regulatory Affairs (QA/RA)
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