Quality Systems Supervisor

3 weeks ago

Laconia, United States Viant Medical Full time

Under the direction of the Quality Manager, this position is responsible for t

he Coordination of Quality System Management Activities (inclusive of Internal/External Audits, Training, Document Control, Label Printing, RMA Support) assigned to support Site Compliance. This role will supervise all Quality Systems personnel and is responsible for ensuring the safety and accuracy of all Quality Systems Activities and maintaining all necessary documentation.

The Quality Systems Supervisor position plays a key role for the Quality System team at the Viant Laconia, NH facility. MAIN JOB RESPONSIBILITIES:

Leadership Exhibits the Viant Medical Values (Teamwork, Customer Oriented, Be Agile, Integrity, Own It, Servant Leadership) Provide Daily Supervisor direction, analysis and recommendations for Quality Systems maintaining compliance to ISO Regulations and Site Requirements Provide Daily Supervisor direction, analysis and recommendations for Labelling to successfully release Production Travelers in a timely and cost effective manner based on business needs Propose and Lead implementation of continuous improvement projects Oversees (With Manager and Focus Factory Input) Associate Development and Training related to QMS Support for all Focus Factories and NPD Projects Plans, coordinates, and directs Annual QMS Training Plan designed to ensure FDA and ISO 13485 Standards are understood and Communicated Is responsible for providing guidance and planning for Annual Record Activities to ensure that Viant is in line with all standards Plans, promotes, and organizes training activities related to Quality Systems Take action to resolve Organizational updates observed in the Quality System (Where Necessary) Train employees on existing and new procedures (SOP’s) as required Responsible for Metric Development and Goal Setting for Direct Reports Functional Execution Act as a liaison between the Quality Systems (Labelling, Document Control, QS Administration) group and :

Planning/Operations to align schedules, priorities, andadjust accordingly for Traveler (Label) availability Quality/Engineering to ensure Change Order (Actions and Training) activities are understood and appropriately completed

(With consideration for the QS impact) QC to consider Resource Cross-Training for labelling (as necessary)

Maintain company compliance with FDA Quality Systems Regulations and ISO 13485 standards Direct support for FDA and ISO inspections and registration Provide explanation and follow up resolutions to RMA/Field Complaint Aging Metrics adjusting resources (With Quality Manager Support) when necessary Work in conjunction with production planning to follow job schedule and assign resources to Labelling based on training and experience. Suggest overtime to management as required to support labelling/job schedules Investigate and Support RMAs related to customer complaints or requests Compiles and writes training material and conducts training sessions on quality Systems activities Develop and initiates standard methods for Offsite Storage Management, Electronic Change Management, Regulations Management, Etc. Author Impact Assessment and Delegates work related to Updated External Standards Support Supplier Quality/Quality Engineering with the Compilation of Part Qualification deliverables (As available) Participate in Correction/Corrective Action resolution of complex problems (Where Applicable) Provide oversight and assign resources to eQMS (Electronic Quality Management System) closures through Document Release and Training Completion Compliance Provide customer related quality and regulatory inquiries support Direct support for FDA and ISO inspections Adheres to Viant Values and suitably represents Viant’s best interests during Customer engagements and Audits Complies with all safety and quality requirements Supports Viant QMS Activities ensuring procedures are compliant to applicable sections of FDA quality system regulation and ISO 13485 regulation. Supervisory (Individual/roles reporting into) Performs other functions as required or duties as assigned Knowledge/Education:

Associates degree in Scientific or Business discipline; or with exception, Certified Lead ISO 13485 Auditor plus 5 years’ experience considered Job Experience:

Proven track of added responsibility- represented by 2-3 years’ Increasing responsibility (Supervisor or Lead) Preferred 3-5 years’ experience in Quality Systems and/or Quality Assurance within Medical Device (or with exception comparable field) manufacturing Strong written and verbal communication skills (Inclusive of negotiation and conflict navigation skills) Ability to work well independently and with fellow team members Attention to detail and organization skills Computer skills with proficiency in Microsoft Outlook and Microsoft Office, Training Database(s)-Microsoft Access Metric Reporting through Excel or other systems Experience reading External Standards Experience with Change Control ( Electronic Systems preferred, paper-based to be considered ) eQMS familiarity and usage (ETQ Reliance Preferred) Demonstrated leadership skills to lead a team Flexible nature enabling Team to perform various job duties, meet deadlines and multi-task as necessary. Physical Requirements:

Excellent vision and hand-eye coordination Extended periods of walking/moving, bending, lifting, and standing Frequently required to lift up to 50 lbs., occasionally lifting up to 70lbs., occasionally more, but will require team lifting or use of a lift assist during these circumstances Must be able and willing to wear personal protective equipment as required including:

Protective eyewear Ear plugs Protective gowning (CME Guidelines, Safety Shoes, Apron, Respirator, Safety Shield)

Schedule Requirements:

8 hour shift Monday to Friday Swing Shift (preferred across shifts for continuity in Labelling) Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

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