Smiths Machine

Senior Quality Assurance Manager {SE}

Smiths Machine • $90K — $120K *
Olive Branch, MS 38654In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline or equivalent experience.
  • 5-10 years of quality systems experience in medical device manufacturing.
  • 3-5 years of management experience.
  • In-depth knowledge of FDA 21 CFR Part 820 and ISO 13485 standards.
  • ASQC and/or ASQE certification preferred.
  • Proficiency in MS Office applications.
  • Six Sigma certification (Black Belt or Green Belt) is advantageous.

Responsibilities

  • Lead and enhance the Quality Management System (QMS) to meet regulatory requirements.
  • Serve as primary contact for quality-related audits and inspections.
  • Oversee complaint handling, corrective action, and risk management processes.
  • Ensure compliance and effectiveness of manufacturing and inspection processes.
  • Drive data-driven decision-making to improve quality systems and manufacturing controls.
  • Monitor quality metrics to identify issues and improve performance.
  • Collaborate with cross-functional teams to define and maintain product quality standards.

Benefits

  • Professional development opportunities and training programs to support career growth.
  • Engagement in continuous improvement initiatives within a regulated environment.
  • Opportunity to lead and influence quality practices across the organization.
  • Contribute to the overall patient safety through quality oversight.
  • Involvement with compliance to industry standards and best practices.
Full Job Description
Summary:

The Senior Quality Assurance Manager is responsible for leading the Quality Assurance function and ensuring the organization's Quality Management System (QMS) is effectively implemented, maintained, and continuously improved in compliance with applicable regulatory standards, customer requirements, and internal quality objectives. This position provides strategic leadership for quality systems, regulatory compliance, audit readiness, risk management, and continuous improvement initiatives within a regulated manufacturing environment.

Essential Duties and Responsibilities:
  • Lead, maintain and continuously improve the Quality Management System (QMS) in alignment with applicable regulatory requirements.
  • Serve as primary quality leader for internal, customer, and regulatory audits and inspections
  • Oversee CAPA, NCR, complaint handling, and escalation processes to ensure timely investigation, containment, root cause analysis, implementation and effectiveness verification.
  • Ensure manufacturing and inspection processes are compliant, effective, and consistently executed through floor presence, audit, and process monitoring.
  • Drive risk-based decision making across quality systems, supplier quality, manufacturing controls, and process improvement.
  • Monitor and analyze quality metrics, trends, and KPIs to identify systemic issues, improve performance, and support management review activities.
  • Partner with Operations, Engineering and Manufacturing to ensure product quality requirements are defined, implemented and maintained.
  • Manage internal audit programs, supplier audits, and external customer/regulatory audits including preparation, execution, response management, and closure activities.
  • Ensure Device History Records (DHRs), quality records, and documentation are complete, accurate, inspection ready, and maintained in accordance with document control requirements.
  • Oversee supplier quality activities including supplier qualification, monitoring, risk assessment, corrective action and Approved Supplier List (ASL)
  • Ensure training programs are established and maintained to support competency, compliance and effectiveness of personnel performing quality-related activities.
  • Assist in investigations involving product nonconformance, escapes, complaints, audit findings, and process failures using structured problem-solving methodologies such as 5-Why, Fishbone and FMEA.

Education and Experience:
  • A minimum of a Bachelor's degree is required, preferably in a scientific discipline. Equivalent related experience may be accepted
  • 5-10 years' hands-on experience with quality systems supporting medical device manufacturing. Experience with machined/mechanical components a strong plus
  • 3-5 years management experience
  • In depth working knowledge of FDA 21 CFR Part 820; Quality System Regulation
  • Familiar with ISO 13485 Medical device directive
  • ASQC and/or ASQE certification a plus
  • Proficient with MS Office applications
  • Six Sigma Black Belt or Green Belt training a plus

Job Knowledge, Skills and Abilities:
  • Must have strong leadership and decision-making skills with the ability to work constructively in difficult situations both internally and externally (with customers and suppliers).
  • Strong verbal, writing, communication, and computer skills.
  • Strong analytical and problem-solving skills with good experimental and documentation habits
  • Strong multitasking skills with the ability to work in a highly dynamic environment
  • Detail oriented with a high level of emphasis on accuracy and completeness

Physical Demands:
  • Light to moderate physical exertion required
  • Regularly required to stand, reach and move about the facility
  • Lifting/carrying Maximum lbs: 25

About Smiths Machine

Smiths Machine is a manufacturing company that specializes in precision machining and assembly services. The company was founded in 1980 and is headquartered in Indianapolis, Indiana. Smiths Machine has a team of experienced machinists and technicians who use state-of-the-art equipment to produce high-quality parts and components for various industries, including aerospace, defense, medical, and transportation. The company's services include CNC machining, turning, milling, grinding, and assembly. Smiths Machine is committed to providing its customers with high-quality products and services and has a reputation for delivering on-time and on-budget.
Learn more about Smiths Machine
Size
15,050 employees
Industry
Manufacturing & Automotive
NASDAQ
SMGZY
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Smiths Machine

  • Smiths Machine
    Quality Manager
    $75K — $95K *
    Blandon, PA 19510 (Berks County)
    3 days ago
    Manufacturing & Automotive
    In-Person
  • Smiths Machine
    Segment Director of HR
    $100K — $130K *
    West Bloomfield, MI 48322 (Oakland County)
    3 days ago
    Manufacturing & Automotive
    In-Person
  • Smiths Machine
    Segment Director of HR
    $100K — $130K *
    Bloomfield Hills, MI 48304 (Oakland County)
    3 days ago
    Manufacturing & Automotive
    In-Person
  • Smiths Machine
    Senior Quality Assurance Manager {SE}
    $90K — $120K *
    Olive Branch, MS 38654 (Desoto County)
    3 weeks ago
    Pharmaceuticals & Biotech
    In-Person
  • Smiths Machine
    Quality Engineer
    $70K — $95K *
    Philadelphia, PA 19120 (Philadelphia County)
    3 weeks ago
    Healthcare
    In-Person

More Pharmaceuticals & Biotech Jobs

Find similar Senior Quality Assurance Manager {SE} jobs:

NationwideOlive Branch, MS