11 days old

Quality Manager

Kelly Services
Winston-Salem, NC 27199
Quality Manager (Winston-Salem, NC)

Client in Medical Device Manufacturing is in need of a Quality Manager. This is a Direct Hire role.

The Quality Manager will be responsible for managing regulatory processes (audit preparation, 510's, MDR's, CE Marking requirements, etc.), and, will also supervise Quality Engineering Team and small Microbiology Team. 4-5 Direct Reports for this role (Lab Supervisor and Quality Engineers, Dotted Quality Lab Supervisor).

Primary Responsibilities:

Manages Quality/Regulatory staff and activities for quality system requirements, including: internal and external audits, document control, final product release, complaint handling, corrective actions, incoming inspection activities, deviations, management review, quality system/GMP training, corrections and removals, regulatory reporting obligations (recalls, FSCAs, adverse event reporting, and vigilance reporting), post market surveillance, content of promotional materials, nonconforming materials, sterilization and environmental monitoring programs.

Ensures the promotion and awareness of regulatory and customer requirements throughout the organization.

Maintains product quality by enforcing quality policies, procedures, and government requirements.

Acts as Quality Control liaison between organization and customers as applicable.

Serves in capacity as Person Responsible for Regulatory Compliance (PRRC) within the meaning of the EU.

Responsible for maintaining ISO 13485 and MDR certifications.

Interpret and communicates international regulatory product requirements and as applicable submits and maintains international product registrations.

Assists with the Quality and Regulatory Planning in conjunction with company strategic objectives.

Determines Quality Control metrics and ensures their compilation for data analysis and overall trending, including Key Performance Metrics for review during Management Review.

Assists in the determination of requirements for and submission of 510(k)s.

Manage technical documentation of CE Marked products, including responsibility for preparation and approval of declarations of conformity.

Oversees scheduling and responses of audits by certifying bodies and customers.

Identify and communicate changes to domestic and regulatory requirements.

Responsibility for ensuring the conformity of products is appropriately checked in accordance with quality system requirements prior to the release and, when necessary, certifies finished goods.

Provides oversight to sterilization processes.

Reviews and approves validation documentation, product specifications, and standard operating procedures, and any revisions to these documents by ensuring they are conducted in accordance with the requirements of the FDA, ISO and any international regulatory agencies.

Review and authorize deviations and, when necessary, facilitate appropriate review boards for deviations and specification changes.

Collaborates with other members of management to develop new product and engineering designs.

Review and support customer advisories, post-market surveillance and responsibility for disposition of authorization returns as applicable.

Support training management systems, including manual and electronic training.

Assist manufacturing with Quality Control related issues to improve efficiency and decrease waste.

Monitors nonconforming product disposition and control, advise senior management, as necessary.

Support the evaluation of raw material out of specifications and determining disposition of any rejects, quarantines, etc.

Ensures label claims and content of promotional materials meets domestic and international regulatory requirements.


4-year college degree or higher in a science or engineering discipline.

Minimum of 5 years medical device manufacturing

Regulatory/ quality experience, preferably in an FDA environment with on-site manufacturing.

Extensive knowledge of world-wide regulatory requirements, including ISO 13485, EU MDR, and US medical device Quality System Requirements 21 CFR 210, 211 and 820.

Minimum of 4 years managing direct reports.

Direct experience with audits and inspections by regulatory authorities.

Knowledge of 510(k), MDR and CE Marking requirements, and experience playing an active role in submissions that led to approval for commercialization.

Familiarity with global and regional trends in regulatory affairs.

Demonstrated successful track record in development and implementation of international compliance strategies.

Six Sigma Green Belt certification preferred.


**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2021-09-10 Expires: 2021-10-11

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Quality Manager

Kelly Services
Winston-Salem, NC 27199

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