Tecomet, Inc · 1 week ago
Quality Assurance and Regulatory Manager
Manchester, NH
Full-time
Onsite
Mid, Senior Level
3+ years expTecomet, Inc is a company focused on quality and regulatory affairs, and they are seeking a Quality Assurance and Regulatory Manager to lead the quality management systems program. The role involves ensuring compliance with FDA and ISO regulations, maintaining quality systems, and promoting a culture of continuous improvement throughout the organization.
ManufacturingPrecious Metals
Responsibilities
Maintain and work towards the continual improvement of the ISO-13485 program and all associated functions including management review, internal and external audits, and associated corrective and preventive actions (CAPAs)
Act as the management representative for the Tecomet-OEM Solutions Lansing Quality System with authority and responsibility for:
Ensuring the quality system is established, implemented and maintained in accordance with International Standard and regulatory requirements
Reporting on the performance of the quality system to Tecomet-OEM Solutions Lansing management for review and as a basis for further improvement and maintaining effectiveness of the quality system
Ensuring and promoting the awareness of regulatory and customer requirements throughout the organization
Act as Lead Auditor to the QMS Internal Audit program
Establish and maintain quality management systems that comply with the FDA 21 CFR guidelines, mainly Part 820
Assist in coaching and training of personnel with the QMS
Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans
Assist in process validations as needed
Records retention/archives management
Maintain a culture where safety, quality, schedule and cost are the main focal points with a continuous improvement mentality
Project a positive and professional image of the company and of management to employees at all levels
Responsible to handle human resource responsibilities in a fair, consistent, unbiased, confidential and positive manner while abiding by all laws, policies and procedures
Responsible for interviewing, providing training, counsel and evaluations, discipline and termination of employees
Promote and develop plans with Tecomet-OEM Solutions Lansing Customers to certify Tecomet-OEM Solutions Lansing preferred supplier
Develop and maintain customer relationships
Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality costs
Optimize manufacturing process run time by identifying and eliminating production failures
Coach and provide training for Quality Engineers, Six Sigma Green Belts and Quality Inspectors
Measure the effectiveness of the systems in place, report back to upper management and develop assessments and corrective action plans
Determine if a potential supplier has the basic systems and machine capabilities in place prior to placing an order with that supplier
Develop and administer systems that facilitate the certification of suppliers, subsequently reducing and/or eliminating Tecomet-OEM Solutions Lansing receiving inspection time and cost
Participate in the Material Review Board process
Follow-up on all internal and external corrective action responses
Internal & external audits and supplier approvals
Oversee special processes validations
Oversee gage control
Device pre-sterile packaging and sterilization requirements
Maintain a culture where safety, quality, schedule and cost are the main focal points with a continuous improvement mentality
Project a positive and professional image of the company and of management to employees at all levels
Responsible to handle human resource responsibilities in a fair, consistent, unbiased, confidential and positive manner while abiding by all laws, policies and procedures
Responsible for interviewing, providing training, mentoring and evaluations, discipline and termination of employees
Qualification
Required
Associates Degree or ASQ CQE and/or CQA Certification may be adequate if the experience time is double
Three years manufacturing experiences
ASQ Certified Quality Auditor or equivalent
ISO/FDA Lead Assessor and/or Auditor
Preferred
RAB & AMSE Certification preferred
Company
Tecomet, Inc
Tecomet develops proven, full-spectrum scalable manufacturing solutions for leading medical device technology, aerospace, and defense companies for whom exceptional quality is critical.
1001-5000 employees
H1B Sponsorship
Tecomet, Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2017-05-01Acquired
Leadership Team
Jason Brasile
Executive Vice President & CFO
Jenifer L. Zbiegien, GPHR, CPSP
Executive Vice President & Chief HR Officer
Recent News
GlobeNewswire
2026-01-16
2026-01-16
2025-11-07
Company data provided by crunchbase